PINNACLE 2218-90-054Recalls & reported problems
Depuy (Ireland) · PINNACLE GRIPPER 54mm · Class 1
All models of PINNACLE (198)
Data updated Oct 16, 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 10603295102298), received between Jun 18, 2018 and Apr 23, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Break; Break
IT WAS REPORTED THAT THE BROKEN TAB ON PINNACLE AB GRIPPER 54MM. OPENED SECOND TRAY FOR BACK UP INSTRUMENT ONLY TO FIND 54MM GRIPPER ON SECOND TRAY ALSO HAD A BROKEN TAB. THIS WOULD HAVE ALSO OCCURRED PRIOR TO THIS CASE. WAS ABLE TO STILL IMPLANT AND SEAT LINER BUT CONCERN OVER STRUCTURAL INTEGRITY OF GRIPPER FOR FUTURE CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21893161 ↗MalfunctionApr 23, 2025Break; Break
IT WAS REPORTED THAT THE BROKEN TAB ON PINNACLE AB GRIPPER 54MM. UNSURE EXACTLY WHEN BROKEN (NOTIFIED BEFORE CASE), WOULD HAVE BEEN DURING A PREVIOUS OPERATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21893037 ↗MalfunctionApr 12, 2019Break; Material Discolored; Break; Material Discolored
REASON FOR REVISION: PRE-PROSTHETIC FRACTURE OF FEMORAL COMPONENT & DISLOCATION. PRIMARY IMPLANT DATE: NOT AVAILABLE. ISSUE: AB GRIPPER INSERTION INSTRUMENT BROKE AT THE TIME OF USE, A SMALL PIECE WAS RETRIEVED FROM THE PATIENT, THE PROCEDURE WAS COMPLETED WITHOUT THE INSTRUMENT. SURGERY DELAYED LESS THAN 5MINS.
Patient problems: Not Applicable
MAUDE report 8508550 ↗MalfunctionJun 18, 2018Break; Break
THR; SURGEON (B)(6) HOSPITAL (B)(6) 2018 - TAB HAS BROKEN OFF PINNACLE 54MM AB GRIPPER . NO AE TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7609219 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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