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PINNACLE 2218-87-364Recalls & reported problems

Depuy (Ireland) · PINNACLE ALTER BEARING INSTRUMENT TRIAL 64OD x 36ID · Class 1

All models of PINNACLE (198)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295101970), received between May 4, 2021 and Aug 15, 2022 — classified as 2 malfunctions.

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
  • Scratched Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE SCREW HAS COME OUT OF THE TRIAL, TRIAL IS NOT BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15224851 ↗
  • MalfunctionMay 4, 2021Scratched Material; Scratched Material

    A TOTAL 5 OF 36MM TRIAL LINERS HAVE SUFFERED SOME WEAR AND TEAR. THERE ARE GOUGES IN THE MATERIAL AND THEREFORE SITE WILL NOT STERILIZE AND REPROCESS THESE TRIAL LINERS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11772476 ↗

Other TEMPLATE devices

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Sources and updates

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