SELF CENTERING 2055-52-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 52OD 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 sizing tool used to check fit during hip replacement surgery. The 24 reports mostly describe worn, scratched trials with size markings that are hard to read, and trials that do not fit or get stuck on their handles, with issues found before or after surgery. There are no deaths and no injuries 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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295084693), received between Apr 19, 2018 and May 26, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility9
- Scratched Material8
- Illegible Information7
- Naturally Worn6
- Contamination /Decontamination Problem2
- Crack1
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient6
- Not Applicable1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
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 25276635 ↗MalfunctionMay 20, 2026Device-Device Incompatibility
IT WAS REPORTED THAT UNIPOLAR ADAPTER TRIAL WAS COMPLETELY STUCK IN 52 MOD ENDO TRIAL. CANNOT PRY IT OUT WHATSOEVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230680 ↗MalfunctionSep 8, 2025Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT CUTS INTO TRIAL ARE TOO DEEP FOR SPD TO ACCEPT. BRINGS ISSUE THAT THEY CANNOT FULLY STERILIZE INTO DEEP CUTS AND BACTERIA CAN STILL LIVE IN THERE. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22998680 ↗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 21273366 ↗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 20441516 ↗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 20439286 ↗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 20326172 ↗MalfunctionNov 2, 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. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18055930 ↗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 17818213 ↗MalfunctionAug 3, 2023Crack; Scratched Material; Crack; Scratched Material
IT WAS REPORTED THAT THE HEMI WAS DAMAGED INTRAOPERATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17451934 ↗MalfunctionMay 10, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HEMI HEAD WOULD NOT SEPARATE FROM THE ADAPTER TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16905156 ↗MalfunctionApr 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED WHITE SPOTS WERE FOUND ON BIPOLAR TRIALS. TRIALS WERE NOT USED IN SURGERY. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16831716 ↗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 14316646 ↗MalfunctionDec 16, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE CATHCART HEAD IS WORN. INSERTER HANDLE NOT ENGAGING SECURELY. NO DELAY TO SURGERY OR HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13019026 ↗MalfunctionAug 26, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE MOD CATHCART HEADBALL TRIAL IS WORN TOO MUCH AND WILL NOT ATTACH TO HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12370265 ↗MalfunctionMar 30, 2021Scratched Material; Scratched Material
MODULAR HEAD BALLS HAVE DAMAGE, (GOUGES, CHIPS AND SCRAPES) MAKING IT DIFFICULT FOR STERILE PROCESSING TO CLEAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11591001 ↗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 11581057 ↗MalfunctionMar 17, 2020Scratched Material; Scratched Material
IT WAS REPORTED THAT THE 52MM MODULAR CATHCART TRIAL IS SCRATCHED ENOUGH THAT IT CAN NO LONGER BE USED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9841692 ↗MalfunctionOct 21, 2019Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIAL HAS DEEP GOUGES IN IT FROM WEAR AND NEEDS TO BE REPLACED. SEND REPLACEMENT P1 TO MUSC. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9214997 ↗MalfunctionAug 21, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE LOCK OF THE BIPOLAR TRIAL HANDLE (MANUFACTURED BY TANAKA MEDICAL INSTRUMENTS) DID NOT FUNCTION WHEN IT WAS ATTEMPTED TO CONNECT WITH THE CUP TRIALS DURING THE BHA SURGERY ON (B)(6) 2019. THE SURGEON HAD TO PUT LITTLE FORCE TO CONNECT THEM AND COULD LOCK HOWEVER IT WAS NOT ABLE TO SEPARATE AFTER THAT. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. AS A RESULT OF CONFIRMING ON (B)(6) 2019 IN THE OPERATION ROOM, THE 4 CUP TRIALS (P/N: 205550000, 205551000, 205552000, 205556000) WERE NOT ABLE TO CONNECT WITH BIPOLAR TRIAL HANDLE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Not Applicable
MAUDE report 8918092 ↗MalfunctionJan 9, 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 8232695 ↗MalfunctionDec 13, 2018Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn
THE TRIAL HEADS DETACHED FROM THE NECK SEGMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8159693 ↗MalfunctionSep 17, 2018Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn
DURING REMOVAL OF THE TRIAL IT WAS NOTICEABLY SCRATCHED AND CUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7882542 ↗MalfunctionApr 19, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THREE INSTRUMENTS DID NOT FUNCTION PROPERLY DURING THE CASE. INSTRUMENTS WOULD NOT LOAD INTO THE EXCEL T-HANDLE. THE STRAIGHT TRIAL HANDLE (MOD ENDO) WOULD NOT SNAP INTO THE TRIAL HEADS. THE 52 HEAD TRIAL WOULD NOT ACCEPT A TRIAL SPACER. IT WOULD NOT SIT FLUSH INTO THE HEAD. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7442802 ↗
Other TEMPLATE devices
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- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- 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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