PINNACLE 2218-28-146Recalls & reported problems
Depuy (Ireland) · PINNACLE BANTAM TRIAL LINER 46OD x 28ID + 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295100317), received between Oct 19, 2017 and Nov 6, 2023 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (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
- Naturally Worn2
- Break1
- Crack1
- Loss of or Failure to Bond1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2023Break; Crack; Break; Crack
LOANER SET ACETABULAR CUP LINER TRIAL CRACKED AND BROKE INTO 2 PIECES. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18081002 ↗MalfunctionJan 24, 2022Naturally Worn; Naturally Worn
PARTS ARE STRIPPED AND WOULD NOT SCREW TOGETHER. NO FRAGMENTS PRODUCED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13338590 ↗MalfunctionJan 24, 2022Naturally Worn; Naturally Worn
PARTS ARE STRIPPED AND WOULD NOT SCREW TOGETHER. NO FRAGMENTS PRODUCED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13338525 ↗MalfunctionOct 1, 2019Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIAL LINER WAS DAMAGED WHEN REMOVING IN. SENT BACK FOR A NEW ONE. INSTRUMENT ONLY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9141245 ↗InjuryOct 19, 2017Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE PINNACLE LINER TRIAL SCREW TIPS BROKE OFF DURING SURGERY. DISCARDED BY THE HOSPITAL.
Patient problems: No Information
MAUDE report 6961379 ↗
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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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