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PINNACLE 2218-28-250Recalls & reported problems

Depuy (Ireland) · PINNACLE TRIAL LINER LIPPED 50OD x 28ID · 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 10603295100447), received between Oct 20, 2022 and Oct 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Detachment of Device or Device Component1

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.

  • MalfunctionOct 20, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT AT THE TIME THE TEST INSERT WAS BROKEN, CHIPS WERE LEFT IN THE ACETABULAR PART OF THE PATIENT. BUT THE DOCTOR CLEANED IMMEDIATELY AFTER THE EVENT. THE CLEANING, WHICH WAS CARRIED OUT BY THE DOCTOR, CONFIRMED THAT THERE WERE NO FRAGMENTS LEFT IN THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15638683 ↗

Other TEMPLATE devices

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Sources and updates

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