SELF CENTERING 2055-47-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 47OD x 28ID · Class 1
All models of SELF CENTERING (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy self-centering modular trial head used to try sizes during hip replacement surgery. The 29 reports mostly describe worn or scratched sizing markings that became hard to read during surgery, plus cracked or deformed parts and drills that broke. No deaths and no injuries were reported, and 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295084648), received between Nov 17, 2017 and May 26, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Illegible Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Illegible Information11
- Device-Device Incompatibility7
- Naturally Worn6
- Scratched Material5
- Material Deformation3
- Appropriate Device Problem Term/Code Not Available2
- Break2
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Consequences Or Impact To Patient3
- Insufficient Information2
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 29 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 25284319 ↗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 25281458 ↗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 25276421 ↗MalfunctionApr 23, 2026Crack; Illegible Information
IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THERE APPEARED TO BE LITTLE CRACKS ON THE PRODUCT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967237 ↗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 22998677 ↗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 22141451 ↗MalfunctionMar 20, 2025Crack; Crack
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP SURGERY, AND THE DILL BITS BROKE AND THE MOD ENDO HEAD CRACKED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21654910 ↗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 21273052 ↗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 20668915 ↗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 20441128 ↗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 20439081 ↗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 20302315 ↗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 19919742 ↗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 19919732 ↗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 19644593 ↗MalfunctionJun 7, 2024Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT BIPOLAR SHELL WAS CHIPPED AND WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19483653 ↗MalfunctionApr 26, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT WAS SCUFFED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19197451 ↗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 18056064 ↗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 17779989 ↗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 16831713 ↗MalfunctionOct 3, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT HEAD TRIAL IS SCRATCHED THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15531393 ↗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 14316831 ↗MalfunctionSep 2, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SPACER TRIALS WOULD NOT FIT PROPERLY INTO THE 47MM TRIAL ENDO HEAD. NO SURGICAL DELAY WAS ENCOUNTERED. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12416075 ↗MalfunctionApr 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DURING THE PROCEDURE, THE BIPOLAR CUP TEST REMAINED INSIDE THE PATIENT AND IT BECAME DIFFICULT TO EXTRACT IT. THE SPECIALIST DECIDED TO EXTRACT IT WITH A FORCEPS CAUSING DAMAGE TO THE CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11732978 ↗MalfunctionOct 8, 2019Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS PRIOR TO STERILIZATION, IT WAS NOTICED THE SIZE 44, 45, 46, 47, AND 48 HEAD TRIALS WOULD NOT STAY ON THE TRIAL HANDLE APPROPRIATELY. THEY ARE EASY TO PULL OFF. THESE WERE NOT USED IN SURGERY AND SURGERY WAS NOT DELAYED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9168091 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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