PINNACLE 2218-52-045Recalls & reported problems
Depuy (Ireland) · PINNACLE DUAL MOBILITY LINER TRIAL 52/45 · Class 1
All models of PINNACLE (198)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle liner trial is a sizing tool used to test fit during hip replacement surgery. The 41 reports mostly describe the trial bending, cracking or breaking during fitting or tray setup. There are no deaths and 1 injury mentioned. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295520559), received between Jan 19, 2021 and Apr 29, 2026 — classified as 1 injury, 40 malfunctions.
The most frequently reported specific device problem is “Break” (30 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
- Break30
- Crack7
- Detachment of Device or Device Component3
- Illegible Information1
- Loss of or Failure to Bond1
- Material Deformation1
- Material Integrity Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information9
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Material Deformation
IT WAS REPORTED THAT THE PINNACLE DUAL MOBILITY LINER TRIAL BENT WHILE TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034873 ↗MalfunctionApr 2, 2026Break
IT WAS REPORTED THAT THE LINER TRIAL WAS BROKEN UPON TRAY ASSEMBLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769634 ↗MalfunctionFeb 20, 2026Break
ADDITIONAL INFORMATION STATES THAT THERE WAS NO FRAGMENT LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400973 ↗MalfunctionAug 26, 2025Break; Break
IT WAS REPORTED THAT CENTRAL SCREW BROKE THROUGH LINER TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22898056 ↗MalfunctionAug 19, 2025Break; Break
IT WAS REPORTED THAT THE DM LINER TRIAL BROKE, BLACK POLY EXTRACTOR TIP BROKE OFF, T-HANDLE AND CORKSCREW KEEP DISCONNECTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841227 ↗MalfunctionMay 5, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING CASE. THERE WAS A 15 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962853 ↗MalfunctionApr 1, 2025Crack; Crack
IT WAS REPORTED THAT TRIAL LINER CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21743742 ↗MalfunctionJan 28, 2025Break; Break
IT WAS REPORTED THAT THE DUAL MOBILITY LINER TRIAL BROKE WHEN TRYING TO REDUCE.
Patient problems: Insufficient Information
MAUDE report 21254074 ↗MalfunctionDec 31, 2024Break; Break
IT WAS REPORTED THAT THE 52X45 PINNACLE DUAL MOBILITY LINER TRIAL CHIPPED WHILE TAKING IT OUT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21046990 ↗MalfunctionNov 14, 2024Crack; Illegible Information; Crack; Illegible Information
ADDITIONAL INFORMATION RECEIVED STATES THAT THE PLASTIC TRIAL LINER WAS CRACKED NEAR THE LIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20684181 ↗MalfunctionOct 25, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE FOLLOWING DEVICE WAS RECEIVED FOR ANALYSIS: PRODUCT CODE: 221852045. LOT: AZ337544. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20533514 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED THAT THE TOP OF THE LINER TRIAL HAS BEEN SNAPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20229807 ↗MalfunctionAug 22, 2024Break; Break
IT WAS REPORTED THAT THE SURGEON TIGHTENED THE THREADED LOCKING POST OF THE TRIAL LINER INTO THE IMPLANTED CUP AND THE TRIAL LINER BROKE. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20032463 ↗MalfunctionAug 8, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE LINER TRIAL WAS DAMAGED WHILE TRIALING.
Patient problems: Insufficient Information
MAUDE report 19939789 ↗MalfunctionJun 25, 2024Break; Break
IT WAS REPORTED THAT THE CONNECTION SCREW SNAPPED.
Patient problems: Insufficient Information
MAUDE report 19608098 ↗MalfunctionMay 17, 2024Break; Break
DURING THA THE LINER TRIAL BROKE. TRIAL WAS REMOVED, BOTH PIECES WERE RETRIEVED AND SURGERY FINISHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19346486 ↗MalfunctionMay 1, 2024Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN LINER. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19220779 ↗MalfunctionMar 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
LINER CENTER PIECE BECAME DISASSOCIATED FROM THE LINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18972766 ↗InjuryFeb 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
ADDITIONAL INFORMATION WAS RECEIVED: 1. NO. THERE WAS NO DELAY. 2. PRODUCTS HAD BEEN IN FOR YEARS AND THERE WAS NO PRIOR RECORD OF SURGERY WE COULD ACCESS TO GET THE INFORMATION. WE KNEW THAT IT WAS A LG+ BASED ON THE POLY AS WE WERE ABLE TO IDENTIFY THE LG+ MARKING BUT ANY ADDITIONAL NUMBERS WERE NOT READABLE. 3. PATELLA WAS DAMAGED WITH RETRACTORS WHILE PERFORMING THE REVISION SO HE DECIDED TO REPLACE THE POLY BUTTON.
Patient problems: Insufficient Information
MAUDE report 18695470 ↗MalfunctionFeb 7, 2024Break; Crack; Detachment of Device or Device Component; Break; Crack; Detachment of Device or Device Component
YES. IT WAS BROKEN IN TWO PIECES. BOTH WERE RETURNED TO THE OFFICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18660077 ↗MalfunctionNov 17, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL LINER WAS OVERTIGHTENED AND IT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18160162 ↗MalfunctionOct 12, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL BROKE INTRA-OPERATIVE.
Patient problems: Insufficient Information
MAUDE report 17919155 ↗MalfunctionJul 12, 2023Crack; Crack
IT WAS REPORTED THAT THE TRIAL WAS CRACKED DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17307264 ↗MalfunctionMay 30, 2023Break; Break
DURING TRIALING THE LINER TRIAL CENTER PIECE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17018961 ↗MalfunctionMay 23, 2023Break; Break
IT WAS REPORTED THAT WHILE SCREWING DOWN THE 52/45 PINNACLE DUAL-MOBILITY LINER TRIAL, THE TRIAL CRACKED ALONG THE APEX OF THE LINER. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16984227 ↗
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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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