SELF CENTERING 2055-50-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 50OD x 28ID · Class 1
All models of SELF CENTERING (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy hip head trial is a reusable instrument surgeons try during hip replacement surgery before fitting the real implant. Reports mostly describe wear found when staff inspect or reprocess it after surgery — scratches, grooves, chipped or cracked rims, and warped parts that would not take a handle — plus size markings that could not be read during an operation and trials that would not fit. The 45 reports describe no deaths and no injuries, and 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
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10603295084679), received between Oct 6, 2017 and May 26, 2026 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (17 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
- Device-Device Incompatibility17
- Scratched Material11
- Illegible Information10
- Naturally Worn6
- Break3
- Crack3
- Material Deformation2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient9
- Insufficient Information1
- No Code Available1
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Illegible Information
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A FEMORAL HEAD REPLACEMENT SURGERY FOR FEMORAL NECK FRACTURE ON FEMUR. THE SIZE MARKINGS WERE NOT VISIBLE DURING THE OPERATION THE SURGERY WAS COMPLETED SUCCESSFULLY WITH SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25283697 ↗MalfunctionMay 26, 2026Illegible Information
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A FEMORAL HEAD REPLACEMENT SURGERY FOR FEMORAL NECK FRACTURE ON FEMUR. THE SIZE MARKINGS WERE NOT VISIBLE DURING THE OPERATION THE SURGERY WAS COMPLETED SUCCESSFULLY WITH SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25283432 ↗MalfunctionMay 26, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY. DURING VISUAL EXAMINATION IT WAS DETERMINED THE DEVICES WERE WORN. (B)(4) AND (B)(4) ARE RELATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276554 ↗MalfunctionFeb 11, 2026Material Deformation
IT WAS REPORTED THAT THE 50 MOD ENDO/BIPOLAR TRIAL WAS WARPED. AS A RESULT, ATTACHING THE TRIAL HANDLE WAS VERY DIFFICULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316695 ↗MalfunctionDec 17, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT DURING STERILE PROCESSING STAFF IDENTIFIED DEEP SCRATCHES AND GROOVES ON THE MODULAR ENDO HEAD TRIALS. THE EVENT DID NOT OCCUR DURING SURGERY, AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828713 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT THE STERILISING UNIT SAID THE BIPOLAR 50/28 INSTRUMENT TRIAL HAD A CHUNK OUT OF THE RIM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569277 ↗MalfunctionJun 17, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT THE SPACER TRIAL WOULD NOT FIT INTO HEAD TRIAL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22241372 ↗MalfunctionMay 2, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT ITEMS WERE SCRATCHED AND CHIPPED. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE DID NOT OCCUR DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21953604 ↗MalfunctionMay 2, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT ITEMS WERE SCRATCHED AND CHIPPED. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE DID NOT OCCUR DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21953600 ↗MalfunctionMar 25, 2025Break; Break
IT WAS REPORTED THAT THE 50MM OD 28MM ID HEAD BROKE DURING THE PROCEDURE. THE BIPOLAR CLIPPING RING ALSO SNAPPED DURING TRIAL STAGE. THIS HAS CAUSED THE TRAY TO BE UNUSABLE DUE TO COMMON INSTRUMENT USAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21687010 ↗MalfunctionFeb 20, 2025Break; Break
IT WAS REPORTED THAT THE PART IS BROKEN. THERE WERE NO PATIENT INVOLVEMENT, ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21426850 ↗MalfunctionJan 30, 2025Illegible Information; Illegible Information
IT WAS REPORTED THAT THE DEVICE WORN OFF BIPOLAR TRIALS FOR SIZE NUMBERS, NO SURGERY WAS DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21273123 ↗MalfunctionOct 17, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information
IT WAS REPORTED THAT HEAD TRIALS DID NOT FIT ON TRIAL STICK AND SIZES ARE NOT VISIBLE. THESE WERE FOUND AFTER THE CASE SO THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469667 ↗MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information
IT WAS REPORTED THAT HEAD TRIALS DID NOT FIT ON TRIAL STICK AND SIZES ARE NOT VISIBLE. THESE WERE FOUND AFTER THE CASE SO THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20441442 ↗MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information
IT WAS REPORTED THAT THE HEAD TRIALS DO NOT FIT ONTO TRIAL STICK. THE SIZES ARE NOT VISIBLE ON THE HEAD TRIALS. THESE WERE FOUND AFTER THE CASE SO THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20439292 ↗MalfunctionSep 25, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
ADDITIONAL INFORMATION RECEIVED STATES THAT THE PRODUCTS WERE WORN, AND THE SIZES WERE NOT VISIBLE. THE LOT NUMBERS WERE NOT VISIBLE ON THE HEAD TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20302318 ↗MalfunctionAug 21, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DIFFICULT TO SNAP HEAD TRIAL ONTO TRIAL SHAFT.
Patient problems: Insufficient Information
MAUDE report 20021945 ↗MalfunctionApr 26, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT WAS SCUFFED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19197602 ↗MalfunctionNov 2, 2023Device-Device Incompatibility; Scratched Material; Illegible Information; Device-Device Incompatibility; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE TRIALS ARE ALL DAMAGED AND UNABLE TO READ THE SIZES. THEY ALSO HAVE DEEP SCRATCHES AND CUTS IN THEM DUE TO NOT LOCKING IN THE HANDLES CORRECTLY. THEY HAVE BEEN DAMAGED DUE TO NOT BEING ABLE TO GET THEM OFF THE HANDLES WITHOUT USING SURGICAL INSTRUMENTS TO GET THEM OFF. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18056317 ↗MalfunctionSep 20, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS HAVE BECOME DAMAGED. THE WRITING FOR THE TRIAL SIZE HAS RUBBED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17779990 ↗MalfunctionJul 11, 2023Naturally Worn; Naturally Worn
IT WAS DISCOVERED THAT THE THREADS ON A 50MM MOD ENDO TRIAL WERE STRIPPED PREOPERATIVELY ON (B)(6) 2023. SURGICAL DELAY IS UNKNOWN. THIS REPORT IS FOR S/C & MOD CATH TRL 50/28. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17300267 ↗MalfunctionJul 11, 2023Naturally Worn; Naturally Worn
IT WAS DISCOVERED ON (B)(6) 2023 THAT THE THREADS ON A 50MM MOD ENDO TRIAL WERE STRIPPED. SURGICAL DELAY IS UNKNOWN. THIS REPORT IS FOR S/C & MOD CATH TRL 50/28. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17300198 ↗MalfunctionJun 1, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HEAD TRIAL WOULD NOT ACCEPT TRIAL HANDLE OR TRIAL SPACERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17042759 ↗MalfunctionMay 9, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT THE HEAD TRIAL WAS DAMAGED WITH LARGE SCRATCHES. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16895384 ↗MalfunctionSep 19, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAIL HEAD WONT FIT ON TRIAL HANDLE. PLEASE REPLACE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15446298 ↗
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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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