SELF CENTERING 2055-16-000Recalls & reported problems
Depuy (Ireland) · SELF CENTERING MODULAR CATHCART BIPOLAR TRIAL RETAINING CLIP 28mm · Class 1
All models of SELF CENTERING (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Self Centering trial retaining clip has 131 adverse event reports on record, with no deaths and 1 injury. The reports mostly describe the clip breaking, cracking, or wearing down, and some mention lot numbers that became unreadable. Several say the clip no longer stayed secure, and many note there was no consequence to the patient. There are no recalls naming 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
- 132
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 10603295084501), received between Aug 18, 2017 and Sep 10, 2026 — classified as 1 injury, 131 malfunctions.
The most frequently reported specific device problem is “Break” (72 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
- Break72
- Device-Device Incompatibility39
- Crack9
- Material Deformation9
- Naturally Worn9
- Material Twisted/Bent7
- Detachment of Device or Device Component4
- Unintended Movement4
Patient problems
- No Clinical Signs, Symptoms or Conditions80
- No Consequences Or Impact To Patient25
- Insufficient Information20
- No Code Available10
- No Information5
- Not Applicable1
Recent adverse event reports
The 25 most recent of 132 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
It was reported that the bipolar TRL retaining clip was broken. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713106 ↗MalfunctionApr 24, 2026Crack; Illegible Information
IT WAS REPORTED THAT THE LITTLE CRACKS APPEAR ON THE PRODUCTS AND LOT NUMBERS ARE UNREADABLE ON THE PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987989 ↗MalfunctionApr 24, 2026Crack; Illegible Information
IT WAS REPORTED THAT THE LITTLE CRACKS APPEAR ON THE PRODUCTS AND LOT NUMBERS ARE UNREADABLE ON THE PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987985 ↗MalfunctionApr 6, 2026Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT, BIPOLAR CLIP, WAS CRACKED AND WILL NO LONGER STAY SECURE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790770 ↗MalfunctionFeb 25, 2026Break
ADDITIONAL INFORMATION RECEIVED: A. DID IT BROKE INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY OF THE INSTRUMENT. IS IT BENT, CRACKED, STRIPPED, WORN OR CROSS THREADED? - THE INSTRUMENT WAS WORN. B. WERE THERE ANY FRAGMENTS GENERATED? IF YES, WERE ALL THE PIECES RETRIEVED? - NO FRAGMENTS WERE GENERATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24442458 ↗MalfunctionFeb 2, 2026Break
IT WAS REPORTED THAT MOD ENDO ORANGE RINGS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233308 ↗MalfunctionFeb 2, 2026Break
IT WAS REPORTED THAT MOD ENDO ORANGE RINGS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233231 ↗MalfunctionFeb 2, 2026Break
IT WAS REPORTED THAT MOD ENDO ORANGE RINGS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233162 ↗MalfunctionFeb 2, 2026Break
IT WAS REPORTED THAT MOD ENDO ORANGE RINGS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233122 ↗MalfunctionDec 26, 2025Break; Break
IT WAS REPORTED THAT THE BIPOLAR RING WAS BROKEN DURING A HIP SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO FRAGMENTS WERE GENERATED.
Patient problems: Insufficient Information
MAUDE report 23897084 ↗MalfunctionNov 13, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT SURGEON STRUGGLED TO GET BIPOLAR TRIAL HEAD ON THE NECK OF THE IMPLANTED STEM. AFTER MANY TRIES, THEY EXAMINED THE TRIAL AND NOTICED THE TRIAL HEAD (28+5) AND THE 28 BIPOLAR RETAINING CLIP TRIAL WERE DAMAGED. NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23546861 ↗MalfunctionNov 11, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE SNAP RING IS CRACKED AND DOESN'T LOCK INTO BIPOLAR PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526628 ↗MalfunctionNov 11, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE SNAP RING IS CRACKED AND DOESN'T LOCK INTO BIPOLAR PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526587 ↗MalfunctionNov 11, 2025Break; Break
DAMAGED CATHCART BIPOLAR TRIAL INSTRUMENTS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522808 ↗MalfunctionOct 27, 2025Break; Break
IT WAS REPORTED THAT A WORN BIPOLAR SNAP RING HAD BROKEN. IT DID NOT HAPPEN IN SURGERY. THE PIECE WAS BROKEN REMOVING FROM BIPOLAR HEAD POST SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389256 ↗MalfunctionOct 21, 2025Break; Break
IT WAS REPORTED THAT THE BIPOLAR RING TRIAL COMPONENT BROKE. ALL PIECES WERE REMOVED; NO ADVERSE EFFECTS TOWARD THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350221 ↗MalfunctionOct 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT RETAINING CLIP NO LONGER RETAINS 28 HEAD INSIDE BIPOLAR SHELL. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348278 ↗MalfunctionJul 9, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT BIPOLAR RETAINING CLIP HAS DEFORMED DUE TO ONGOING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22458964 ↗MalfunctionJul 8, 2025Break; Break
IT WAS REPORTED THAT THE PART WAS FOUND BROKEN IN TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22439233 ↗MalfunctionJul 2, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN RETAINING CLIP. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22381960 ↗MalfunctionJun 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE RING WON'T STAY SNAPPED IN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22178941 ↗MalfunctionJun 5, 2025Break; Break
IT WAS REPORTED THAT RED CLIPS WERE BROKEN DURING TRAY ASSEMBLY. METAL HEAD SIZERS HAD PITTED/RUST MARKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153287 ↗MalfunctionJun 5, 2025Break; Break
IT WAS REPORTED THAT RED CLIPS WERE BROKEN DURING TRAY ASSEMBLY. METAL HEAD SIZERS HAD PITTED/RUST MARKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153270 ↗MalfunctionJun 5, 2025Break; Break
IT WAS REPORTED THAT RED CLIPS WERE BROKEN DURING TRAY ASSEMBLY. METAL HEAD SIZERS HAD PITTED/RUST MARKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153262 ↗MalfunctionJun 5, 2025Break; Break
IT WAS REPORTED THAT RED CLIPS WERE BROKEN DURING TRAY ASSEMBLY. METAL HEAD SIZERS HAD PITTED/RUST MARKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153244 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page