PINNACLE 2217-00-056Recalls & reported problems
Depuy Orthopaedics, Inc. · PINNACLE ALTER BEARING EXTRACTOR BODY 56mm · Class 1
All models of PINNACLE (182)
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 10603295097303), received between Jul 1, 2021 and Feb 5, 2025 — 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
Most reported problems
Device problems
- Break4
- Detachment of Device or Device Component1
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.
MalfunctionFeb 5, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, AFTER THE CERAMIC LINER WAS EXTRACTED, THE SCRUB NURSE NOTICED THE MISSING TIP ON THE 56 EXTRACTOR BODY. BROKEN TIP WAS RETRIEVED AFTER CERAMIC LINER WAS EXTRACTED. SURGEON WAS STILL ABLE TO USE THE EXTRACTOR TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21315968 ↗MalfunctionNov 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE PINNACLE EXTRACTION SET WAS USED TODAY, AND IT LOOKS AS THOUGH A COUPLE OF THE ITEMS ARE BROKEN. THE FEET ARE MISSING.
Patient problems: Insufficient Information
MAUDE report 18169365 ↗MalfunctionAug 10, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT HAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300093 ↗MalfunctionJul 1, 2021Break; Break
HIP WAS REVISED FOR TRUNNION WEAR. 36MM HEAD REVISED. CERAMIC LINER EXCHANGED FOR SMALLER POLY. I DON¿T BELIEVE THE REVISION WAS REPORTED SEPARATELY AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12099119 ↗
Other WRENCH devices
- MONARCH 277040510Medos International Sàrl · WRENCH199 reports
- PINNACLE 2217-50-008Depuy (Ireland) · WRENCH108 reports
- SIGMA 96-1673Depuy (Ireland) · WRENCH102 reports
- P.F.C. 86-5189Depuy (Ireland) · WRENCH92 reports
- Veptr 03.641.004Synthes GmbH · WRENCH86 reports
- RECLAIM 2975-00-300Depuy (Ireland) · WRENCH51 reports
- PINNACLE 2217-50-006Depuy (Ireland) · WRENCH34 reports
- NA 388.261Synthes GmbH · WRENCH32 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page