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PINNACLE 2218-62-053Recalls & reported problems

Depuy (Ireland) · PINNACLE DUAL MOBILITY LINER TRIAL 62/53 · Class 1

All models of PINNACLE (198)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295520535), received between Dec 15, 2022 and Sep 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break4

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Insufficient Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 28, 2026Break

    It was reported that the Dual Mobility (DM) liner trial broke.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50912987 ↗
  • MalfunctionJan 23, 2025Break; Break

    IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 21219252 ↗
  • MalfunctionMar 16, 2023Break; Break

    IT WAS REPORTED THAT THE TRIAL DUAL MOBILITY LINER BROKE WHEN TRYING TO PLACE IN ACETABULAR CUP. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16554242 ↗
  • MalfunctionDec 15, 2022Break; Break

    PINNACLE DUAL MOBILITY LINER TRIAL BROKE WHEN BEING INSERTED, PERHAPS DUE TO SURGEON USING EXCESSIVE FORCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15986016 ↗

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Sources and updates

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