SELF CENTERING 2055-48-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 48OD 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 trial head used to try hip implant sizes during surgery. The 43 reports mostly describe worn, scratched, grooved or cracked parts, plus size markings that could not be read during an operation, and trial parts that would not come apart after sterilization. No deaths or injuries were reported, and most mentions came with no effect on the patient. There are no recalls naming this device, and the report count was the same in the past 12 months as the 12 before.
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
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295084655), received between Jul 17, 2018 and May 26, 2026 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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 Incompatibility15
- Illegible Information14
- Scratched Material8
- Naturally Worn7
- Material Deformation5
- Crack3
- Break2
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Consequences Or Impact To Patient5
- Insufficient Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 43 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 25282037 ↗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 25281774 ↗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 25276469 ↗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 24967232 ↗MalfunctionApr 22, 2026Scratched Material
ADDITIONAL INFORMATION RECEIVED: 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 24954500 ↗MalfunctionDec 17, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT DURING STERILE PROCESSING STAFF IDENTIFIED DEEP SCRATCHES AND GROOVES ON THE MODULAR ENDO HEAD TRIALS. THE EVENT DID NOT OCCUR DURING SURGERY, AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828543 ↗MalfunctionAug 13, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WAS CRACKED HEAD BEARS NO LONGER HOLD HEADS ON TRIAL HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22793375 ↗MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STERILIZATION WAS UNABLE TO GET THE 48MM SHELL AND THE -3 SPACER APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22641476 ↗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 21953596 ↗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 21272997 ↗MalfunctionJan 9, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT TWO ENDOMODULAR HEAD TRIALS WERE FOUND TO HAVE WEAR AND SHARP POINTS AROUND THE OUTER DOME. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21111875 ↗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 20669432 ↗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 20441131 ↗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 20439078 ↗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 20302289 ↗MalfunctionSep 17, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT UPON INSPECTION THE FOLLOWING PARTS WERE FOUND.S/C & MOD CATH TRL 48/28 - FADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20235668 ↗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 19919736 ↗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 19919675 ↗MalfunctionJul 24, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SURGEON HAD A HARD TIME PUTTING LINER SLEEVE INSIDE ENDO TRIAL. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817549 ↗MalfunctionJul 10, 2024Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE TAPER WAS STUCK INSIDE THE HEAD, AND BOTH WERE CRACKED. THEY NEEDED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19715478 ↗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 18056028 ↗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 17779993 ↗MalfunctionJul 18, 2023Break; Scratched Material; Break; Scratched Material
ADDITIONAL INFORMATION RECEIVED. A. WHEN WAS THE ISSUE IDENTIFIED ( PRE OP/ INTRA OP/POST OP)? THE ISSUE WAS IDENTIFIED, DURING CLEANING AND STERILIZATION. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17343768 ↗MalfunctionMay 5, 2023Scratched Material; Scratched Material
SCUFFED DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN. DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN. DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN., PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4) DEVICE PROPERTY OF -- NONE, DEVICE IN POSSESSION OF -- NONE, (B)(4) DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16878595 ↗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 16831709 ↗
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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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