SELF CENTERING 2055-12-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 10603295084471), received between Jul 19, 2017 and Sep 29, 2026 — classified as 1 injury, 144 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (79 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931386 ↗
• MalfunctionMay 1, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE BEARINGS ON THE TRIAL HANDLE WERE FUSED. THEY DID NOT ALLOW THE TRIAL HANDLE TO THREAD ONTO THE HEAD TRIALS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059330 ↗
• MalfunctionApr 2, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SPRING MECHANISM IN THE DEVICES HOLDS BIO BURDEN, RESULTING IN THE FACILITY'S DECISION TO DISCONTINUE STERILIZATION BY SPD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769119 ↗
• MalfunctionMar 17, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE SHELL TRIALS WILL NOT SNAP ONTO THE STRAIGHT SHELL TRIAL INSERTER. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621279 ↗
• MalfunctionFeb 23, 2026Contamination /Decontamination Problem

  IT WAS REPORTED BEHIND THE INSTRUMENTS` SPRING BALLS BLOOD, FLUID, TISSUE, ETC. IS STILL APPARENT AFTER REPROCESSING. INSTRUMENT IS NOT POSSIBLE TO BE REPROCESSED PROPERLY. NO ADVERSE PATIENT IMPACT, NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420617 ↗
• MalfunctionFeb 23, 2026Contamination /Decontamination Problem

  IT WAS REPORTED BEHIND THE INSTRUMENTS` SPRING BALLS BLOOD, FLUID, TISSUE, ETC. IS STILL APPARENT AFTER REPROCESSING. INSTRUMENT IS NOT POSSIBLE TO BE REPROCESSED PROPERLY. NO ADVERSE PATIENT IMPACT, NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24419927 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT S/C TRIAL HANDLE AND S/C TRIAL HANDLE ANGLED WERE DUE TO AN INABILITY TO DISASSEMBLE THE INSTRUMENTS, WHICH PREVENTED CLEANING BEHIND THE SPRING BALLS. THE EVENT WAS IDENTIFIED IN THE CENTRAL STERILE SERVICES DEPARTMENT, AND THE CUSTOMER DECLINED TO REPROCESS THE INSTRUMENTS. THERE WAS NO ADVERSE PATIENT IMPACT OR SURGICAL DELAY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400162 ↗
• MalfunctionFeb 19, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT AFTER THE SURGICAL PROCEDURE, BEHIND THE INSTRUMENTS SPRING BALLS BLOOD, FLUID, TISSUE, WERE STILL APPARENT AFTER REPROCESSING. THE INSTRUMENT WAS NOT POSSIBLE TO BE REPROCESSED PROPERLY. NO ADVERSE PATIENT IMPACT, NO SURGICAL DELAY REPORTED. S/C TRIAL HANDLE - 205512000 (205512000): NOT APPLICABLE. LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393178 ↗
• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT MOD ENDO STRAIGHT TRIAL HANDLE WOULD NOT ENGAGE WITH TRIAL HEADS. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172865 ↗
• MalfunctionJan 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLES DID NOT CONNECT PROPERLY TO THE TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053798 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT HANDLE DOES NOT ENGAGE PROPERLY TO TRIAL HEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750734 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT HANDLE DOES NOT ENGAGE PROPERLY TO TRIAL HEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750703 ↗
• MalfunctionNov 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE MODULAR ENDO TRIALS HANDLES HAVE 4 BEARINGS ON THE END OF THE HANDLE AND THE INSIDE HAS BIO BURDEN IN THEM THAT FACILITY COULD NOT GET OUT. THEY WASHED THEM AND PUT THEM IN SONIC SEVERAL TIMES AND STILL BIO BURDEN LEAKED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490831 ↗
• MalfunctionNov 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE MODULAR ENDO TRIALS HANDLES HAVE 4 BEARINGS ON THE END OF THE HANDLE AND THE INSIDE HAS BIO BURDEN IN THEM THAT FACILITY COULD NOT GET OUT. THEY WASHED THEM AND PUT THEM IN SONIC SEVERAL TIMES AND STILL BIO BURDEN LEAKED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490772 ↗
• MalfunctionNov 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE MODULAR ENDO TRIALS HANDLES HAVE 4 BEARINGS ON THE END OF THE HANDLE AND THE INSIDE HAS BIO BURDEN IN THEM THAT FACILITY COULD NOT GET OUT. THEY WASHED THEM AND PUT THEM IN SONIC SEVERAL TIMES AND STILL BIO BURDEN LEAKED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490705 ↗
• MalfunctionNov 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE MODULAR ENDO TRIALS HANDLES HAVE 4 BEARINGS ON THE END OF THE HANDLE AND THE INSIDE HAS BIO BURDEN IN THEM THAT FACILITY COULD NOT GET OUT. THEY WASHED THEM AND PUT THEM IN SONIC SEVERAL TIMES AND STILL BIO BURDEN LEAKED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490662 ↗
• MalfunctionSep 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL BIPOLAR HEADS WOULD NOT SNAP ONTO THE TRIAL HANDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23115069 ↗
• MalfunctionAug 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE WILL NOT ACCEPT MOD ENDO HEAD TRIAL AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839659 ↗
• MalfunctionAug 15, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT OVER 100 HEMIARTHROPLASTIES SURGERIES, THE S/C TRIAL HANDLE HAS ENDURE NUMEROUS IMPACTIONS. THE RESULT OF BEARINGS ARE FAULTY AND CANNOT PROVIDE A FULLY SEATED TRIAL. THE BEARINGS ARE FROZEN AND CANNOT MOVE FREELY. NO SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. PATIENT STATUS IS UNKNOWN, OR IF PROCEDURE WAS SUCCESSFULLY COMPLETED OR PART OF A CLINICAL STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816439 ↗
• MalfunctionAug 1, 2025Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PLASTIC OF THE T-HANDLES ARE BROKEN AND HOLDING BIO BURDEN IN THE BALL PIECES THAT THE TRIAL HEAD SNAPS ONTO. THIS DID NOT HAPPEN DURING SURGERY AND WAS NOTED BY THE STERILE PROCESSING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689393 ↗
• MalfunctionJul 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BOTH THE CURVED AND STRAIGHT BIPOLAR HEAD TRIAL HANDLES HAD BIOBURDEN STUCK IN THE CREVICES; DIFFERENT TECHNIQUES WERE TRIED, BUT THE DEVICES WERE UNABLE TO BE CLEANED. THIS WAS DISCOVERED IN THE STERILE PROCESSING DEPARTMENT; THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530053 ↗
• MalfunctionJun 26, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE BALL BEARINGS SEIZED UP. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341902 ↗
• MalfunctionApr 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HOSPITAL WANTED ALL HANDLES REPLACED DUE TO THE HANDLES BEING HARD TO CLEAN. THERE WAS BIO BURDEN AROUND BEARINGS. EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890288 ↗
• MalfunctionApr 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HOSPITAL WANTED ALL HANDLES REPLACED DUE TO THE HANDLES BEING HARD TO CLEAN. THERE WAS BIO BURDEN AROUND BEARINGS. EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890196 ↗
• MalfunctionMar 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS RECEIVED FOR ANALYSIS. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21699294 ↗