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Compress® Device 178353Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304509054), received between Feb 8, 2021 and Feb 8, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

  1. Aug 21, 2019Terminated

    Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

    Z-0519-2020 · Root cause: Environmental control · FDA record ↗

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryFeb 8, 2021Fracture; Fracture

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY AND FOUR MONTHS AFTER THE PROCEDURE SUBSEQUENTLY WAS REVISED DUE TO IMPLANT FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: No Code Available

    MAUDE report 11294190 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.