PINNACLE 2218-56-049Recalls & reported problems
Depuy (Ireland) · PINNACLE DUAL MOBILITY LINER TRIAL 56/49 · Class 1
All models of PINNACLE (198)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295520573), received between May 18, 2021 and Sep 14, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Crack5
- Material Twisted/Bent2
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
- Entrapment of Device1
- Mechanical Jam1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755412 ↗MalfunctionApr 28, 2026Crack
IT WAS REPORTED THAT A CRACK WAS NOTICED IN THE PLASTIC TRIAL DURING INSPECTION IN THE LOCAL OFFICE. NO SURGERY INFORMATION WAS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25020262 ↗MalfunctionMar 19, 2026Crack
IT WAS REPORTED THAT THE SURGEON WAS TRYING TO SCREW THE DUAL MOBILITY LINER TRIAL INTO THE CUP WHEN IT CRACKED ACROSS THE TOP. IT WAS REMOVED AND REPLACED WITH A BACKUP. ALL PIECES WERE ACCOUNTED FOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640972 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, THE PINNACLE DM LINER TRIAL 56_49 WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637848 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, THE PINNACLE DM LINER TRIAL 56_49 WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637823 ↗MalfunctionMay 13, 2025Crack; Crack
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS A CRACK ON THE SIDE OF THE TRIAL. NO FRAGMENTS WERE GENERATED FROM THE CRACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012461 ↗MalfunctionApr 21, 2025Crack; Crack
IT WAS REPORTED THAT 56/49 TRIAL WAS CRACKED.
Patient problems: Insufficient Information
MAUDE report 21877984 ↗MalfunctionAug 15, 2024Break; Break
IT WAS REPORTED THAT THE 56MM DUAL MOBILITY TRIAL BROKE WHEN THE THREADED BOLT SEPARATED FROM THE SHELL/LINER TRIAL. THIS NEEDS TO BE REPLACED. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995754 ↗MalfunctionMar 28, 2023Break; Crack; Break; Crack
ADDITIONAL INFORMATION WAS RECEIVED AND MENTIONED THAT THE LINER TRIAL PLASTIC CRACKED WHEN TRIALLING. IT ALSO STATED THAT THE SCREWDRIVER SNAPPED MID SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16627503 ↗MalfunctionDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13092537 ↗MalfunctionJul 21, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE HEX HEAD PORTION OF THE SCREW IS STRIPPED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12204839 ↗MalfunctionJun 29, 2021Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE TRIAL BROKE INSIDE THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12088830 ↗MalfunctionMay 18, 2021Device-Device Incompatibility; Material Twisted/Bent; Mechanical Jam; Device-Device Incompatibility; Material Twisted/Bent; Mechanical Jam
TRIAL DUAL MOBILITY LINER SIZE 56/49 GOT STUCK IN SHELL CROSS THREADED. WAS UNABLE TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11841104 ↗
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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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