SELF CENTERING 2055-56-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295084730), received between Jan 9, 2019 and Aug 12, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 22787334 ↗
• 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 20441873 ↗
• 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 20439285 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ROD ENDO HEAD TRIALS WERE GETTING OLD AND DO NOT FIT ON THE TRIAL STICK. THESE WERE FOUND AFTER THE CASE SO THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302638 ↗
• MalfunctionFeb 26, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THERE WAS A DAMAGED UNIPOLAR HEAD. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777381 ↗
• 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. ON (B)(6) 2023. D. WHAT IS THE ALERT DATE OF THE COMPLAINT? WHEN WERE YOU MADE AWARE OF THE EVENT? ON (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 17818246 ↗
• MalfunctionSep 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL AND SPACER COULD NOT BE BE DISASSEMBLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447290 ↗
• MalfunctionJun 24, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED DAMAGED INSTRUMENTS IDENTIFIED BY CSSD. NO PATIENT OR SURGICAL INVOLVEMENT. SURGERY WAS NOT DELAYED. INSTRUMENTS HAVE BEEN TAGGED OUT. NO FRAGMENTS WERE GENERATED. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 56OD X 28ID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14803132 ↗
• MalfunctionMay 9, 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 14338312 ↗
• MalfunctionAug 24, 2020Scratched Material; Scratched Material

  (B)(6) 2020; TRIAL HAS GOUGESAND IS UNABLE TO BE STERILIZED. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10445526 ↗
• MalfunctionAug 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LOCK OF THE BIPOLAR TRIAL HANDLE (MANUFACTURED BY TANAKA MEDICAL INSTRUMENTS) DID NOT FUNCTION WHEN IT WAS ATTEMPTED TO CONNECT WITH THE CUP TRIALS DURING THE BHA SURGERY ON (B)(6) 2019. THE SURGEON HAD TO PUT LITTLE FORCE TO CONNECT THEM AND COULD LOCK HOWEVER IT WAS NOT ABLE TO SEPARATE AFTER THAT. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. AS A RESULT OF CONFIRMING ON (B)(6) 2019 IN THE OPERATION ROOM, THE 4 CUP TRIALS (P/N: 205550000, 205551000, 205552000, 205556000) WERE NOT ABLE TO CONNECT WITH BIPOLAR TRIAL HANDLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 8918079 ↗
• MalfunctionJan 9, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BI-POLAR TRIALS NOT FUNCTIONING PROPERLY AND/OR HARD TO READ. ADDITIONALLY, HANDLES RELEASING TRIALS TOO EASILY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8230736 ↗