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PINNACLE 2218-32-266Recalls & reported problems

Depuy (Ireland) · PINNACLE TRIAL LINER LIPPED 66OD x 32ID · Class 1

All models of PINNACLE (198)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295100997), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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

  • Naturally Worn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionFeb 3, 2022Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THE HOSPITAL HAVE REPORTED A DAMAGED LIPPED TRIAL LINER. NO DELAY IN SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13440260 ↗

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Sources and updates

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