PINNACLE 2218-48-041Recalls & reported problems
Depuy (Ireland) · PINNACLE DUAL MOBILITY LINER TRIAL 48/41 · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295520511), received between Oct 6, 2021 and Oct 28, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Break1
- Crack1
- Material Deformation1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES. CAN YOU PLEASE CLARIFY WHAT YOU MEAN BY "DAMAGED"? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED, OR ANY DEVICE INTERACTION? WORN, BENT, AND SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20551556 ↗MalfunctionJul 11, 2024Break; Break
IT WAS REPORTED THAT THE LINER TRIAL WAS BROKEN DURING NORMAL USE.
Patient problems: Insufficient Information
MAUDE report 19720271 ↗MalfunctionNov 30, 2023Crack; Crack
IT WAS REPORTED THAT THE INSERT TRIAL WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242591 ↗MalfunctionSep 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE METAL INSERT POPPED OUT OF THE PLASTIC TRIAL. ALL PIECES WERE RECOVERED AND DISPOSED OF. NO TIME WAS ADDED TO SURGERY.
Patient problems: Insufficient Information
MAUDE report 17787382 ↗MalfunctionOct 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CENTER SCREW IS MISSING FROM THE DM LINER TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12584525 ↗
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- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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.
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