SELF CENTERING 2055-53-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 53OD x 28ID · Class 1
All models of SELF CENTERING (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295084709), received between Dec 19, 2018 and Apr 1, 2026 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (9 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 Material9
- Illegible Information8
- Device-Device Incompatibility7
- Naturally Worn3
- Break2
- Contamination /Decontamination Problem1
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient3
- Insufficient Information2
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2026Scratched Material
IT WAS REPORTED THAT SPD FOUND A SCUFF ON THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752922 ↗MalfunctionDec 30, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIAL WAS SCRATCHED UP PRETTY BAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926996 ↗MalfunctionApr 1, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE BP HEAD TRIALS ARE SCRATCHED AND THE METAL ON THE INSTRUMENTS ARE PITTED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21740891 ↗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 21273813 ↗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 20441828 ↗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 20439284 ↗MalfunctionSep 27, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE MOD ENDO HEAD TRIALS ARE OLD AND DON'T FIT ON THE TRIAL STICK. THESE WERE FOUND AFTER A CASE SO THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20327513 ↗MalfunctionJan 3, 2024Device-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 18435295 ↗MalfunctionNov 6, 2023Device-Device Incompatibility; Scratched Material; Illegible Information; Device-Device Incompatibility; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE TRIALS ARE 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. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18081128 ↗MalfunctionSep 26, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
INSTRUMENTS HAVE BECOME DAMAGED WRITING FOR THE TRIAL SIZE HAS RUBBED OFF. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 9/15/2023 STATED: B. PLEASE PROVIDE THE LOT NO. OF THE REPORTED DEVICES. -LOT NUMBERS CANNOT BE READ AS THEY HAVE WORN OFF OF THE DEVICES, THERE IS 3 OF EACH INSTRUMENT. C. PLEASE CONFIRM THE DATE OF EVENT, IT HAS BEEN ADDED AS PER THE SOURCE FILE. (B)(6) 2023. D. WHAT IS THE ALERT DATE OF THE COMPLAINT? WHEN WERE YOU MADE AWARE OF THE EVENT? - (B)(6) 2023. E. PLEASE CLARIFY WHAT DOES IT MEAN WITH "INSTRUMENTS HAVE BECOME DAMAGED " THE WRITING ON THE SIDE OF THE TRIALS, WHICH THE SURGEONS NEEDS TO READ TO BE ABLE TO DECIDE WHICH FINAL IMPLANT TO USE IS NO LONGER READABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17818328 ↗MalfunctionJul 14, 2023Break; Contamination /Decontamination Problem; Scratched Material; Break; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT THE PLASTIC WAS CHIPPED OR SCRATCHED.
Patient problems: Insufficient Information
MAUDE report 17326782 ↗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 14316728 ↗MalfunctionMar 29, 2021Scratched Material; Scratched Material
MODULAR HEAD BALLS HAVE DAMAGE, (GOUGES, CHIPS AND SCRAPES) MAKING IT DIFFICULT FOR STERILE PROCESSING TO CLEAN. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11581067 ↗MalfunctionMar 29, 2021Scratched Material; Scratched Material
MODULAR HEAD BALLS HAVE DAMAGE, (GOUGES, CHIPS AND SCRAPES) MAKING IT DIFFICULT FOR STERILE PROCESSING TO CLEAN NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11581056 ↗MalfunctionJan 22, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE MODULAR ENDO HEAD TRIAL GOT STUCK ON TRIAL HANDLE. SURGEON HAD TO HIT IT WITH A MALLET TO REMOVE AND IT BROKE INTO TWO PIECES. ALL PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11216779 ↗MalfunctionNov 12, 2019Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility
IT WAS REPORTED THAT THE BIPOLAR HEAD TRIALS POP OFF THE TRIAL HANDLE VERY EASILY BECAUSE THE INNER RING INSIDE THE HEAD DOES NOT SNAP ON TIGHT ENOUGH TO HOLD. SEND REPLACEMENT FOR THE 2 BIPOLAR HEAD TRIALS TO THE KNOX OFFICE AND WILL SEND THE OLD ONES BACK WHEN MDR # RECEIVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9309829 ↗MalfunctionJan 10, 2019Illegible Information; Illegible Information
IT WAS REPORTED THAT THE BI POLAR TRIALS NOT FUNCTIONING PROPERLY AND/OR HARD TO READ. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8232845 ↗MalfunctionDec 19, 2018Scratched Material; Scratched Material
THE CATHCART HEAD TRIAL HAS DEEP SCRATCHES ON IT CAUSING A STERILIZATION CONCERN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8181657 ↗
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- 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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