SELF CENTERING 2055-51-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295084686), received between Jan 9, 2019 and Apr 22, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Scratched Material

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRIAL DEVICE HAD STRIPED/SCRATCHED BIPOLAR TEST HEADS. IT WAS REPORTED THAT THE DEVICE HAS BEEN IN USE FOR 5 OR 6 YEARS. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954516 ↗
• MalfunctionJan 12, 2026Scratched Material

  IT WAS REPORTED THAT THE PLASTIC IN THE INSTRUMENT HAD SCRATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031980 ↗
• 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 23828536 ↗
• MalfunctionJul 31, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP SURGERY AND BIPOLAR CLAMP RING AND 51/28 TRIAL HEAD WERE DAMAGED DURING DISASSEMBLY. THERE WAS NO DELAY TO SURGERY AND THE PATIENT WAS NOT AFFECTED. THE BIPOLAR HEAD TRAIL AND 28 RETAINING CLAMP RING BOTH HAVE LARGE GASHES ON THEM, WHICH CREATES AN ISSUE WITH THE STERILE PROCESSING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674315 ↗
• MalfunctionJul 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SPD SAID THE INSTRUMENT NEEDED TO BE REPLACED. UPON MANUFACTURERS INVESTIGATION THE INSTRUMENT WAS FOUND TO HAVE SCRATCHES ON THE SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641710 ↗
• MalfunctionMay 30, 2025Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

  IT WAS REPORTED THAT MODULAR ENDO HEAD TRIAL HAS DEEP GROOVES AND SCRATCHES, CREATING POTENTIAL TO HOLD BIOBURDEN. THE EVENT DID NOT HAPPENED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116221 ↗
• 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 21953602 ↗
• 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 21273816 ↗
• 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 20441443 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT THE HEAD TRIALS DO 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 20439287 ↗
• MalfunctionSep 27, 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 20327319 ↗
• 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 20193814 ↗
• MalfunctionJun 20, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE HEAD TRIAL IS SCUFFED.

  Patient problems: Insufficient Information

  MAUDE report 19573910 ↗
• MalfunctionMar 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SPACER DOES NOT FIT IN TRIAL..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895110 ↗
• 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 18056013 ↗
• MalfunctionSep 26, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  INSTRUMENTS HAVE BECOME DAMAGED WRITING FOR THE TRIAL SIZE HAS RUBBED OFF. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 9/15/2023 STATED: B. PLEASE PROVIDE THE LOT NO. OF THE REPORTED DEVICES. -LOT NUMBERS CANNOT BE READ AS THEY HAVE WORN OFF OF THE DEVICES, THERE IS 3 OF EACH INSTRUMENT. C. PLEASE CONFIRM THE DATE OF EVENT, IT HAS BEEN ADDED AS PER THE SOURCE FILE. (B)(6) 2023. D. WHAT IS THE ALERT DATE OF THE COMPLAINT? WHEN WERE YOU MADE AWARE OF THE EVENT? - (B)(6) 2023. E. PLEASE CLARIFY WHAT DOES IT MEAN WITH "INSTRUMENTS HAVE BECOME DAMAGED " THE WRITING ON THE SIDE OF THE TRIALS, WHICH THE SURGEONS NEEDS TO READ TO BE ABLE TO DECIDE WHICH FINAL IMPLANT TO USE IS NO LONGER READABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818339 ↗
• 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 16831719 ↗
• MalfunctionNov 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL HEAD AND SPACER TRIAL ARE STUCK TOGETHER AND CANNOT BE TAKEN APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831581 ↗
• MalfunctionOct 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY WITH THE TRIAL SHELL IN QUESTION. IN THE SURGERY, THE TRIAL SHELL COULD NOT ATTACH TO A HANDLE. IT COULD NOT BE TURNED NORMALLY IN THE DIRECTION MARKED LOCK. THE OTHER TRIAL IMPLANTS WERE ABLE TO ATTACH TO THIS HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580635 ↗
• MalfunctionJun 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE 51 BIPOLAR IS DAMAGED AND NO LONGER IN ACCEPTABLE SHAPE FOR SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632174 ↗
• 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 14316735 ↗
• MalfunctionJul 28, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE MODULAR ENDO TRIAL HEAD GOT DAMAGED WHILE DISLOCATING HIP. NEEDS REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239275 ↗
• MalfunctionMar 29, 2021Scratched Material; Scratched Material

  MODULAR HEAD BALLS HAVE DAMAGE, (GOUGES, CHIPS AND SCRAPES) MAKING IT DIFFICULT FOR STERILE PROCESSING TO CLEAN NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581060 ↗
• MalfunctionJul 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE IS STICKING AND 51 SHELL TRIAL DOESN¿T SEEM TO WANT TO STAY CONNECTED TO HANDLE. NO SURGICAL DELAY. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224553 ↗
• MalfunctionApr 16, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE TRIAL IS SCARRED UP AND DAMAGED. SIZES CAN¿T BE READ EITHER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968817 ↗