SELF CENTERING 2055-44-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 44OD x 28ID · Class 1
All models of SELF CENTERING (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295084617), received between Sep 21, 2018 and Sep 3, 2026 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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
- Device-Device Incompatibility9
- Illegible Information7
- Naturally Worn6
- Scratched Material4
- Break2
- Crack2
- Material Deformation2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient3
- Insufficient Information1
- Not Applicable1
Recent adverse event reports
The 22 most recent of 22 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 50581534 ↗MalfunctionAug 5, 2026Break; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142140 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372436 ↗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 21953603 ↗MalfunctionOct 28, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE CENTRAL STERILE DEPARTMENT STAFF IDENTIFIED DEEP GROOVES IN PLASTIC MODULAR ENDO HEAD TRIAL. POTENTIAL FOR BIO-BURDEN TO REMAIN IN GROOVE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20549657 ↗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 20439833 ↗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 20439092 ↗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 20302282 ↗MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ORANGE RING WOULD NOT SNAP INTO THE TWO MOD ENDO TRIALS. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20193905 ↗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 19919897 ↗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 19919706 ↗MalfunctionJul 2, 2024Crack; Crack
IT WAS REPORTED THAT THE 44 BIPOLAR TRIAL HAD A CRACK IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19660939 ↗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 18056310 ↗MalfunctionOct 5, 2023Illegible Information; Illegible Information
IT WAS REPORTED THAT THE SIZE MARKINGS ON SAID PRODUCT WERE VERY HARD TO READ. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17876372 ↗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 17779928 ↗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 14316734 ↗MalfunctionFeb 7, 2022Crack; Naturally Worn; Crack; Naturally Worn
PLASTIC ON TRIALS CRACKED DUE TO WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13476621 ↗MalfunctionJul 7, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 44 HEAD TRIAL NO LONGER HOLDS UNIPOLAR TRIALS IN PLACE. NO ADDITIONAL INFO. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12129450 ↗MalfunctionMar 16, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE MOD CATHCART SPACERS WILL NOT SIT FLUSH IN TRIAL HEAD. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9835608 ↗MalfunctionJan 30, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SIZE 44MM ENDO HEAD TRIAL WOULD NOT ACCEPT UNIPOLAR SPACE TRIAL TO SEAT FULLY. SURGICAL DELAY OF 2 TO 3 MINUTES.
Patient problems: Not Applicable
MAUDE report 9647913 ↗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 9168095 ↗MalfunctionSep 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SIZE 44 MOD ENDO TRIAL IS COMPROMISED AND THE MOD CATHCART TAPERED SPACERS WILL NOT FULLY SEAT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7899334 ↗
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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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