PINNACLE 2218-50-043Recalls & reported problems
Depuy (Ireland) · PINNACLE DUAL MOBILITY LINER TRIAL 50/43 · Class 1
All models of PINNACLE (198)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295520528), received between Jul 15, 2021 and Jan 23, 2025 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Detachment of Device or Device Component2
- Material Deformation1
- Naturally Worn1
- No Apparent Adverse Event1
- Off-Label Use1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information3
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21219611 ↗MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT CENTRAL STERILE STAFF IDENTIFIED FEMORAL HEAD IMPACTORS WITH DAMAGED TIPS, FEMORAL CANAL PROBE WITH DAMAGED FLUTES WITH THE POTENTIAL TO PRODUCE METAL BURRS, AND PLASTIC TRIAL COMPONENTS WITH DEEP GROOVES AND DAMAGE. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20550736 ↗MalfunctionDec 21, 2023Break; Break
IT WAS REPORTED THAT TRIAL WAS BROKEN WHILE REDUCING HIP.
Patient problems: Insufficient Information
MAUDE report 18379886 ↗MalfunctionDec 20, 2023Break; Break
IT WAS REPORTED THAT THE RIM OF THE 50MM DM LINER TRIAL BROKE WHEN TRIALING. ALL BROKEN PARTS WERE RETRIEVED AND THERE WAS NO SURGICAL DELAY. NO ADVERSE EVENTS TOOK PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18366702 ↗MalfunctionSep 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT METAL INSERT IN THE PINNACLE DM LINER TRIAL POPPED OUT. ALL PIECES WERE RECOVERED AND NO TIME WAS ADDED TO THE CASE.
Patient problems: Insufficient Information
MAUDE report 17739678 ↗MalfunctionAug 16, 2023No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENT HAS AN UNKNOWN ALLEGATION. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17557271 ↗MalfunctionAug 7, 2023Break; Break
IT WAS REPORTED THAT THREADED PART ON THE 50/43 LINER BROKE. THE 60/51 LINER TRIAL IS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17470694 ↗MalfunctionJun 2, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL LINER BROKE DURING SURGERY. ALL PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17052703 ↗MalfunctionMay 3, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL LINER BROKE DURING SURGERY. ALL PIECES WERE RETRIEVED AND THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16859395 ↗MalfunctionMar 6, 2023Break; Break
IT WAS REPORTED THAT THE DM LINER TRIAL WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16486377 ↗MalfunctionOct 18, 2022Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component
LINER TRIAL SCREWS DISENGAGED WHEN ATTEMPTING TO SCREW INTO THE ACETABULAR SHELL. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15624795 ↗MalfunctionJul 27, 2021Break; Break
IT WAS REPORTED THAT THE DM LINER TRIAL BROKE TRYING TO GET IT SEATED IN THE CUP. THE LINER TRIAL BROKE INTO TWO PIECES AND ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12228010 ↗MalfunctionJul 22, 2021Break; Break
IT WAS REPORTED THAT UPON INSPECTION OF TRAYS, 50/43 DUAL MOBILITY CUP LINER WAS FOUND IN TWO PIECES. ALL PIECES WERE FOUND AND WILL BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12211285 ↗MalfunctionJul 15, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. ALL PIECES WILL BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12175816 ↗
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- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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