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OSS™ Orthopedic Salvage System 161071Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

All models of OSS Orthopedic Salvage System (76)

Data updated Oct 18, 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 00880304456174), received between Apr 28, 2021 and Apr 28, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Failure of Implant1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THE LOCKING RING FRACTURE IS WHAT CAUSED THE YOKE TO DISASSOCIATE FROM THE TIBIAL TRAY. THEREFORE, THE LOCKING RING IS THE ONLY REPORTABLE ITEM. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Patient problems: Failure of Implant; Pain

    MAUDE report 11739345 ↗

Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

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