SELF CENTERING 2055-45-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 45OD x 28ID · Class 1
All models of SELF CENTERING (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy self-centering modular hip trial head, a reusable sizing instrument used during hip replacement surgery to try different head and spacer sizes before the real implant goes in. The 32 reports mostly describe worn or scratched surfaces, parts breaking apart during disassembly, and heads that no longer fit or cannot be fully sterilized. No deaths or injuries are reported. There are no recalls naming this device, and reports have dropped from 8 in the prior 12 months to 3.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295084624), received between Jan 9, 2019 and Sep 3, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (13 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 Material13
- Illegible Information10
- Device-Device Incompatibility8
- Naturally Worn8
- Contamination /Decontamination Problem3
- Material Deformation3
- Break2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Consequences Or Impact To Patient4
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Illegible Information
It was reported that the size and product numbers had become unreadable. The event did not happen in surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50581544 ↗MalfunctionSep 3, 2026Illegible Information
It was reported that the size and product numbers had become unreadable. The event did not happen in surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50581541 ↗MalfunctionSep 3, 2026Illegible Information
It was reported that the size and product numbers had become unreadable. The event did not happen in surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50581538 ↗MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT THE SHELL AND THE SPACER BROKE WHEN TRYING TO DISASSEMBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414296 ↗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 25276356 ↗MalfunctionApr 22, 2026Scratched Material
ADDITIONAL INFORMATION RECIEVED: CAN YOU PLEASE CONFIRM WHEN THIS WAS FOUND, PRE, POST, INTRA OP OR DURING CLEANING AND INSPECTION? CLEANING AND INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954501 ↗MalfunctionOct 27, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE CALCAR PLANER SEEMED WARPED AND DID NOT PLANE THE CUT SURFACE SMOOTHLY. FURTHER THE +5 TRIAL SPACER AND THE 45X28 HEADS WERE SEVERELY "SCUFFED AND BATTERED" IN THE SET. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392109 ↗MalfunctionOct 15, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT SHELL WAS SCRATCHED WHILE REMOVING FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23305435 ↗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 22998669 ↗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 22998666 ↗MalfunctionJun 9, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A CUSTOMER INQUIRED ABOUT WEAR PRESENT ON TOTAL JOINT TRIALS. THE WEAR APPEARED TO BE DISPROPORTIONATE TO USUAL USE. THERE IS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22170989 ↗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 22141449 ↗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 21953597 ↗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 21272950 ↗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 20439831 ↗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 20439084 ↗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 20302793 ↗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 19919738 ↗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 19919730 ↗MalfunctionJul 1, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE MOD ENDO 45 AND 47 BIPOLAR TRIAL HEADS WERE DAMAGED. ADDITIONAL INFORMATION: ADDITIONALLY, DEEP GAUGES WERE OBSERVED AT THE BOTTOM SURFACE OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19644582 ↗MalfunctionFeb 16, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMS THAT THERE WERE NO ADVERSE CONSEQUENCES OCCURRED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18720240 ↗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 18056301 ↗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 17779895 ↗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 17326751 ↗MalfunctionJun 20, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE MOD CATHCART HEAD TRIAL WAS WORN. THE NECK TRIAL WAS UNABLE TO SEAT PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17163956 ↗
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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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