PINNACLE 2218-36-162Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER 62OD x 36ID + 4 10 DEG · 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 10603295101314), received between May 17, 2019 and Feb 27, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Naturally Worn2
- Scratched Material2
- Detachment of Device or Device Component1
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LINER TRIAL BROKE DURING INSERTION INTO THE CUP. SCREW FELL OUT OF THE CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16442996 ↗MalfunctionApr 13, 2022Break; Break
IT WAS REPORTED THAT WASHER HOLDING THE SCREW IN PLACE BROKE IN HALF. WASHER WAS DISCARDED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14103243 ↗MalfunctionOct 18, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PINNACLE LINER TRIAL IS JUST WORN FROM USE BEYOND KEEPING STERILE IN WASH. NO PATIENT INJURY. NO DELAY TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12647309 ↗MalfunctionJun 26, 2019Material Discolored; Naturally Worn; Scratched Material; Material Discolored; Naturally Worn; Scratched Material
ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE LOT NUMBERS COULD NOT BE IDENTIFIED BECAUSE THESE WERE SO WORN AND SCRATCHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8736526 ↗MalfunctionMay 17, 2019Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THEY ATTEMPTED TO USE 36X62X+4 10* LINER TRIAL. SET SCREW AND WASHER FELL OUT. NO BROKEN PIECES LEFT IN PATIENT, NO SURGERY DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8621477 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- 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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