{"hq_id":"hq-p-spe-000093","name":"Metal-on-Metal Hip Implant (Cobalt/Chromium Ion Release, Metallosis)","category":{"primary":"specialty","secondary":"medical","tags":["hip implant","metal-on-metal","cobalt","chromium","metallosis","DePuy","recall"]},"product_tier":"SPE","overall_risk_level":"high","description":"Metal-on-metal (MoM) hip implants releasing cobalt and chromium ions into surrounding tissue and bloodstream. DePuy ASR hip implant recalled (2010) — 93,000 patients, highest failure rate of any hip implant in history. Metallosis: toxic metal debris causing tissue necrosis, pseudotumor formation, and systemic cobalt poisoning (neurological, cardiac, thyroid effects). Patients with MoM implants require regular blood cobalt/chromium monitoring. Metal-on-polyethylene and ceramic-on-ceramic are safer bearing surfaces.","synthesis":{"derived_risk_level":"moderate_to_high","synthesis_confidence":0.612,"synthesis_method":"compound_composition","context_used":"human_adult","context_source":"product_users","exposure_modifier":1.4,"vulnerability_escalated":false,"escalation_reason":null,"compounds_resolved":2,"compounds_total":2,"synthesis_date":"2026-05-09","synthesis_version":"1.2.0","methodology_note":"exposure_modifier and adjusted_magnitude are computed from ALETHEIA-calibrated heuristics (route × duration × frequency multipliers, clamped to [0.5, 1.4]). Multipliers are directionally informed by EPA Exposure Factors Handbook (2011) and CalEPA OEHHA but are not regulatory consensus. See /api/methodology for full disclosure."},"hazard_summary":{"sensitive_populations":"MoM hip implant recipients (~500,000 US)","overall_risk":"high","primary_concerns":["Cobalt/chromium ion release causing metallosis and tissue necrosis","Systemic cobalt poisoning: neurological, cardiac, thyroid toxicity","DePuy ASR: highest failure rate in hip implant history (40% at 7 years)","~500,000 US patients with MoM hips requiring monitoring"],"exposure_routes":"Continuous ion release from implanted metal bearing surfaces"},"exposure":{"routes":["dermal"],"contact_types":["skin_prolonged"],"users":["adult"],"duration":"continuous","frequency":"daily","scenarios":["Continuous cobalt and chromium ion release into tissue and blood","Metallosis: toxic tissue necrosis from metal debris","Systemic cobalt poisoning: neurological, cardiac, thyroid effects","DePuy ASR recall: 93,000 patients, highest failure rate"],"notes":"MHRA (UK) 2010: recommended annual blood cobalt/chromium monitoring for all MoM hip patients. DePuy ASR: 40% revision rate at 7 years in some studies (vs <5% for standard bearings). Cobalt blood levels >7 ppb indicate abnormal metal release. MoM hips largely abandoned by orthopedic community — current standard: metal-on-polyethylene, ceramic-on-polyethylene, or ceramic-on-ceramic."},"consumer_guidance":{"usage_warning":"If you have a MoM hip implant: get annual blood cobalt and chromium levels. Report any new symptoms (hip pain, hearing changes, neurological symptoms, thyroid changes) to orthopedic surgeon. Cobalt >7 ppb = abnormal. If needing hip replacement: avoid MoM bearings — request ceramic-on-polyethylene or ceramic-on-ceramic.","safer_alternatives":["Ceramic-on-polyethylene bearing (most common current standard)","Ceramic-on-ceramic bearing (lowest wear debris)","Metal-on-polyethylene (dramatically lower ion release than MoM)","Regular blood monitoring for existing MoM patients"],"red_flags":[{"indicator":"Health claims without FDA approval or clinical evidence","meaning":"Product efficacy unverified.","action":"Consult physician. Check FDA and clinical trial evidence."}],"green_flags":[{"indicator":"FDA-approved, USP-verified, or physician-recommended","meaning":"Verified safety and/or efficacy through established evaluation.","verification":"Check FDA approval status, USP mark, or published clinical evidence."}],"what_to_ask":[{"question":"Is there FDA-approved or peer-reviewed clinical evidence for this product?","why_it_matters":"Health products without evidence may be ineffective or harmful.","good_answer":"FDA-approved or supported by published RCTs.","bad_answer":"Testimonials only or DSHEA-exempt supplement with no clinical evidence."}],"alternatives":[{"name":"Ceramic-on-polyethylene bearing","notes":"most common current standard"},{"name":"Ceramic-on-ceramic bearing","notes":"lowest wear debris"},{"name":"Metal-on-polyethylene","notes":"dramatically lower ion release than MoM"}]},"regulatory":{"applicable_regulations":[{"jurisdiction":"USA","regulation":"FDA Class III Medical Device (Hip Implant)","citation":"21 CFR 888.3310","requirements":"Premarket approval (PMA) required. DePuy ASR voluntarily recalled 2010. FDA issued safety communication on MoM 2013.","compliance_status":null,"effective_date":null,"enforcing_agency":"FDA","penalties":null,"source_ref":null}],"certifications":[],"labeling":{"required_disclosures":[],"prop65_warning":{"required":null,"chemicals":[],"endpoint":null,"notes":null},"ghs_labeling":{"required":null,"signal_word":null,"pictograms":[],"hazard_statements":[],"notes":null},"hidden_ingredients":{"trade_secret_protected":null,"categories_hidden":[],"estimated_count":null,"known_concerns":null,"notes":null},"notes":null},"recalls":[],"regulatory_gap":null,"notes":null},"lifecycle":{"recyclable":false,"disposal_guidance":"Explanted implant: medical waste.","hazardous_waste":false,"expected_lifespan":"10-20_years"},"formulation":{"form":"varies","key_ingredients":[{"hq_id":"hq-c-ino-000113","name":"Cobalt aluminate","role":"implant_alloy","concentration_pct":"cobalt-chromium alloy"},{"hq_id":"hq-c-ino-000085","name":"Chromium(VI) / Hexavalent Chromium","role":"implant_alloy","concentration_pct":"cobalt-chromium alloy"}],"certifications":[]},"materials":{"common":[],"concerning":[],"preferred":[]},"compound_composition":[{"hq_id":"hq-c-ino-000113","compound_name":null,"role":"implant_alloy","typical_concentration":"cobalt-chromium alloy"},{"hq_id":"hq-c-ino-000085","compound_name":null,"role":"implant_alloy","typical_concentration":"cobalt-chromium alloy"}],"identifiers":{"common_names":["metal-on-metal hip implant (cobalt/chromium ion release, metallosis)"],"aliases":[],"manufacturer":null,"brands":[]},"brand_examples":[{"brand":"3M","manufacturer":"3M","market_position":"mass_market","notable":"Safety and specialty product conglomerate"},{"brand":"Honeywell","manufacturer":"Honeywell","market_position":"mass_market","notable":"Safety equipment and technology"},{"brand":"DuPont","manufacturer":"DuPont","market_position":"professional","notable":"Chemical and safety products"}],"brand_examples_disclaimer":"Representative branded products of this category. Concerning ingredients listed in materials.concerning[] apply to the category, not necessarily to every named brand. Specific formulations vary by SKU and may have changed since this record was written; consult the brand's current ingredient label before drawing brand-level conclusions.","sources":[{"type":"expert_curation","name":"ALETHEIA Safety Database","date":"2026-03-25"},{"type":"regulation","title":"FDA Class III Medical Device (Hip Implant) (21 CFR 888.3310)","jurisdiction":"USA","citation":"21 CFR 888.3310","id":"src_5bf5e83c"},{"id":"src_001","type":"epa","title":"EPA CompTox Chemicals Dashboard — DTXSID8050499","url":"https://comptox.epa.gov/dashboard/chemical/details/DTXSID8050499","accessed":"2026-03-12","notes":"Hazard, exposure, and toxicity data","inherited_from_compound":"hq-c-ino-000113"},{"id":"src_002","type":"reference","title":"ATSDR Toxicological Profile — CAS 1345-16-0","url":"https://www.atsdr.cdc.gov/toxprofiledocs/index.html","notes":"Toxicological profile and health effects summary","inherited_from_compound":"hq-c-ino-000113"},{"id":"iarc_ref","type":"regulatory","title":"IARC Monographs on the Evaluation of Carcinogenic Risks to Humans — Chromium, Nickel and Welding (Volume 49)","year":1990,"inherited_from_compound":"hq-c-ino-000085"},{"id":"epa_ref","type":"regulatory","title":"US EPA Integrated Risk Information System (IRIS) — Chromium(VI)","year":2008,"inherited_from_compound":"hq-c-ino-000085"}],"meta":{"schema_version":"4.0.0","last_updated":"2026-03-25","timestamp":"2026-05-14T01:24:08.491Z"}}