SELF CENTERING 2055-43-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 43OD x 28ID · Class 1
All models of SELF CENTERING (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295084600), received between Nov 5, 2018 and Sep 3, 2026 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Illegible Information” (10 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
- Illegible Information10
- Scratched Material7
- Device-Device Incompatibility6
- Naturally Worn4
- Break1
- Detachment of Device or Device Component1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient4
- Insufficient Information1
Recent adverse event reports
The 21 most recent of 21 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 50581529 ↗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 50581526 ↗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 50581522 ↗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 25276292 ↗MalfunctionAug 12, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT HEMI HIP ITEMS ARE SCRATCHED/WORN OUT AND CAN NOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787328 ↗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 20439828 ↗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 20439083 ↗MalfunctionSep 25, 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 20302281 ↗MalfunctionAug 14, 2024Break; Break
IT WAS REPORTED THAT THE BIPOLAR TRIAL WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 19980629 ↗MalfunctionJul 30, 2024Scratched Material; Scratched Material
ADDITIONAL INFORMATION RECEIVED STATED THAT: A. PLEASE CLARIFY WHAT YOU MEAN BY DAMAGED? IS IT BROKEN INTO TWO PIECES, DULL, BENT, CRACKED, STRIPPED, WORN, SCRATCHED, CROSS-THREADED, OR ANY DEVICE INTERACTION ISSUES? - SCRATCHED. B. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? - NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19861060 ↗MalfunctionJul 1, 2024Illegible Information; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENT SIZES ARE NEARLY ILLEGIBLE. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19643056 ↗MalfunctionFeb 16, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT CATH TRIAL IS SCRATCHED AND WORN. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18720360 ↗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 18056253 ↗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 17779889 ↗MalfunctionJan 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE NECK TRIALS WOULD NOT CLICK INTO THE 43 HEAD TRIAL. ALL OF THE OTHER HEAD TRIALS WORKED CORRECTLY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16148293 ↗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 14316743 ↗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 11590985 ↗MalfunctionSep 18, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT THE RING THAT KEEPS THE HEAD TRIAL IN THE BIPOLAR HEAD WOULDN¿T STAY ON TIGHT. THE DOCTOR COMPLAINED HOW THE TRIAL SHOULDN¿T BE COMING APART.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10554559 ↗MalfunctionMar 27, 2020Scratched Material; Scratched Material
NO INFORMATION IS AVAILABLE OTHER THAN THE TRIAL HAS A SCRATCH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9889758 ↗MalfunctionJan 10, 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 8232866 ↗MalfunctionNov 5, 2018Scratched Material; Scratched Material
DEFECT IN TRIAL WAS NOTICED AFTER INSTRUMENTS WERE WASHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8037758 ↗
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- 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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