ANSWER HIP SYSTEM 162501Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304252660), received between Apr 29, 2022 and Apr 29, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Material Erosion” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Erosion1
Patient problems
- Metal Related Pathology1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2022Material Erosion; Material Erosion
IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH SUSPICION OF ADVERSE LOCAL TISSUE REACTION APPROXIMATELY 15 YEARS POST IMPLANTATION. DURING THE REVISION THERE WAS A PSEUDO CAPSULE, CORROSION, LYTIC INFLAMMATION, GRAY STAINING, BLACK LYTIC MEMBRANE MATERIAL FOUND AND BONE DEFECT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Metal Related Pathology
MAUDE report 14250635 ↗
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- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
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- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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