SELF CENTERING 2055-49-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 49OD 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 self-centering modular hemi hip head trial is a reusable sizing trial used during hip surgery to check fit before the real implant goes in. The 31 reports mostly describe worn or scratched surfaces, markings worn off so sizes can't be read, and parts that no longer match other instruments; several were found during sterile processing rather than in the operating room. No deaths or injuries were reported. 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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295084662), received between Dec 27, 2018 and May 26, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (11 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
- Scratched Material11
- Illegible Information10
- Device-Device Incompatibility7
- Naturally Worn6
- Material Deformation4
- Break2
- Contamination /Decontamination Problem1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient5
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 25 most recent of 31 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 25285061 ↗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 25285042 ↗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)_ARE RELATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276516 ↗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 23828705 ↗MalfunctionAug 12, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT HEMI HIP ITEMS ARE SCRATCHED/WORN OUT AND CAN NOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787335 ↗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 21953608 ↗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 21273072 ↗MalfunctionJan 9, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT TWO ENDOMODULAR HEAD TRIALS WERE FOUND TO HAVE WEAR AND SHARP POINTS AROUND THE OUTER DOME. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21111877 ↗MalfunctionJan 2, 2025Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT TRIAL WAS BADLY SCRATCHED AND PLASTIC COULD FLAKE OFF. THIS ISSUE DID NOT HAPPEN IN SURGERY AND WAS FOUND WHEN REASSEMBLING SETS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056236 ↗MalfunctionNov 12, 2024Material Deformation; Illegible Information; Material Deformation; Illegible Information
IT WAS REPORTED THAT TRIAL HEADS WERE WORN AND NUMBERS ARE ILLEGIBLE. ALL PIECES RETRIEVED, NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20669194 ↗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 20441436 ↗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 20439295 ↗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 20302290 ↗MalfunctionSep 10, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE HEAD TRIALS FALL OFF OF BIPOLAR HANDLE TO EASILY. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20179054 ↗MalfunctionSep 9, 2024Scratched Material; Scratched Material
IT WAS REPORTED, THAT THE HEAD TRIALS FALL OFF OF BIPOLAR HANDLE TO EASILY. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20173277 ↗MalfunctionAug 7, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT NUMBERS WERE WORN OFF. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929019 ↗MalfunctionAug 7, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT NUMBERS WERE WORN OFF. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19928998 ↗MalfunctionFeb 16, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT CATH TRIAL IS SCRATCHED AND WORN. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18720213 ↗MalfunctionNov 16, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE EVENT DID OCCUR DURING SURGERY, AND THERE WAS NO DELAY. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18147808 ↗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 18056292 ↗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 17779991 ↗MalfunctionMar 1, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT TWO TRIAL COMPONENTS WERE DIFFICULT TO REMOVE AND PUT BACK TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16461869 ↗MalfunctionNov 28, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT METAL SHARDS FOUND IN TRIAL. WHERE FOUND DURING STERILISATION PROCESS AFTER CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15868914 ↗MalfunctionMay 7, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE SIZING INFORMATION WORN OFF TRIALS DUE TO MULTIPLE AUTOCLAVING/USAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316846 ↗MalfunctionJan 26, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE UNIPOLAR INSERT TRIAL NOT SEATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13357791 ↗
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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 13, 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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