SELF CENTERING 2055-46-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 46OD 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 trial hip head is a sizing trial shell surgeons fit during hip surgery before placing the real implant. The 36 reports mostly describe scratched or chipped surfaces, shells cracking or popping off the trial handle, deep cuts that resist sterilization, and size markings that were hard to read. No deaths or injuries were reported. There are no recalls naming this device, and reports fell from 9 in the prior 12 months to 1 in the most recent.
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
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295084631), received between Mar 19, 2018 and May 6, 2026 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (12 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 Material12
- Device-Device Incompatibility9
- Illegible Information8
- Naturally Worn8
- Break3
- Contamination /Decontamination Problem3
- Material Deformation3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient6
- Insufficient Information2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE BIPOLAR SHELL CRACKED, AND WOULD NOT RETAIN CLIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25091834 ↗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 22998679 ↗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 22998678 ↗MalfunctionAug 8, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A BHA SURGERY FOR PROXIMAL FEMUR FRACTURE. WHEN THE SURGEON WAS CHECKING THE ADHESION OF THE TRIAL SHELL 46MM BY ATTACHING IT TO THE TRIAL HANDLE, THE TRIAL SHELL CAME OFF FROM THE HANDLE. THE TRIAL SHELL WAS PLACED ON THE ACETABULAR SIDE, AND THE SURGEON FIRMLY GRASPED IT WITH KOCHER CLAMP AND REMOVED IT. AT THE TIME, THE TRIAL SHELL WAS DAMAGED AND GOUGED OUT, WHICH RAISED CONCERNS FROM THE OPERATING ROOM NURSE THAT SOME OF THE MATERIAL MIGHT HAVE BEEN LEFT INSIDE THE PATIENT¿S BODY. THE SURGEON IS NOT CONCERNED, BUT THE OPERATING ROOM HAS ASKED THE SALES REPRESENTATIVE TO CHECK WHETHER PART OF THE TRIAL SHELL IS MISSING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 22755211 ↗MalfunctionJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A BHA SURGERY FOR A FEMORAL NECK FRACTURE. DURING THE SURGERY, SIZE MARKINGS ON MULTIPLE PRODUCTS IN THE INSTRUMENT SET WERE FOUND TO HAVE DISAPPEARED AND WERE DIFFICULT TO DISTINGUISH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22141450 ↗MalfunctionMay 29, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE BIPOLAR TRIAL WAS SCRATCHED UP AND THE SURGEON WANTED A REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22103565 ↗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 21953598 ↗MalfunctionMar 3, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRIAL WAS STUCK IN ACETABULUM AFTER IT POPPED OFF TRIAL HANDLE. IT HAD TO DAMAGE WITH RONGEUR TO REMOVE. NO EXTRA TIME NEEDED.
Patient problems: Insufficient Information
MAUDE report 21504490 ↗MalfunctionFeb 10, 2025Illegible Information; Illegible Information
IT WAS REPORTED THAT THE TRIAL WAS WORN. THERE WAS NO SURGERY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343951 ↗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 20668844 ↗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 20441126 ↗MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information
IT WAS REPORTED THAT THE HEAD TRIALS DID 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 20439080 ↗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 20302340 ↗MalfunctionAug 12, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THERE IS SIGNIFICANT WEAR ON MOD-ENDO TRIAL HEADS WHICH NEEDS REPLACING IN ORDER TO BE PROCESSED PER THEIR PROTOCOL. T-HANDLE BECAME LOOSE AND WILL NOT CHUCK ONTO SCREW DRIVERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19959464 ↗MalfunctionAug 6, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THE NUMBERS WERE WORN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919671 ↗MalfunctionAug 5, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THERE WAS SIGNIFICANT WEAR ON MOD-ENDO TRIAL HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19908374 ↗MalfunctionApr 26, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT WAS SCUFFED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19197436 ↗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 18056085 ↗MalfunctionSep 21, 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 17787375 ↗MalfunctionSep 13, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: 1. CAN YOU PLEASE CLARIFY IF WAS THERE PATIENT INVOLVEMENT? YES. 2. WAS THERE ANY ASSOCIATED PATIENT CONSEQUENCES DUE TO THE REPORTED EVENT? NO. 3. WAS THERE ANY ASSOCIATED SURGICAL DELAYS DUE TO THE REPORTED EVENT? NO. 4. WAS THE ASSOCIATED PROCEDURE COMPLETED SUCCESSFULLY? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17738089 ↗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 16831714 ↗MalfunctionJan 10, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SPACER TRIAL WOULD NOT FIT INTO HEAD TRIAL CORRECTLY SO THE PIECES COULD NOT BE USED TO TRIAL THE HEMI HIP. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16135086 ↗MalfunctionJan 10, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE 46MM BI-POLAR TRIAL HEAD GOT ALL SCRATCHED UP WHEN THE DOCTOR REMOVED IT AFTER TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16135050 ↗MalfunctionJan 9, 2023Break; Break
IT WAS REPORTED THAT THE 46 BIPOLAR SHELL SPLIT AND WAS THROWN IN TRASH. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16121590 ↗MalfunctionNov 1, 2022Break; Break
IT WAS REPORTED THAT DURING HIP ARTHROPLASTY, TWO ITEMS WERE DAMAGED DURING SURGERY. WE HAD BACKUP ITEMS AVAILABLE, SO THERE WERE NO DELAYS OR PROBLEMS IN SURGERY BECAUSE OF THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15708200 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page