PINNACLE 2218-36-758Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL ACETABULAR LINER CON +4 10 DEG 36mm ID 58mm OD · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295101475), received between Feb 4, 2025 and Mar 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Crack1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE IS REPORTED DUE TO WEAR AND TEAR OVER THE YEARS. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560216 ↗MalfunctionFeb 4, 2025Crack; Crack
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF IDENTIFIED THAT THE MATERIAL OF A TRIAL WAS CRACKED IN A SEMI-CIRCULAR PATTERN NEAR THE APEX OF THE DOME OF THE INSTRUMENT. THIS INSTRUMENT WAS DEEMED TO BE NO LONGER FUNCTIONAL. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21304904 ↗
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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