NA 2987-06-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295157625), received between Apr 2, 2018 and Nov 15, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DR USED A LPS DISTAL FEMORAL REPLACEMENT FOR A REVISION OF A PERI PROSTHETIC FRACTURE (NOT A J&J PRODUCT) ON THE (B)(6) 2022. HE USED A LPS DISTAL FEMUR WITH SLEEVE ADAPTOR AND UNIVERSAL STEM AND SLEEVE FOR THE FEMORAL IMPLANT COMBINATION. I HAVE BEEN INFORMED THAT THERE WERE CHALLENGES SEPARATING THE 10MM SLEEVE ADAPTOR FROM THE LPS DISTAL FEMORAL TRIAL DURING KIT DECONTAMINATION, AND THAT THE AFFECTED INSTRUMENTS WERE SENT BACK TO THE WA WAREHOUSE FOR COMPLETE SEPARATION FOLLOWING THE HOSPITALS DECONTAMINATION PROCEDURE. I AM NOW BEING TOLD BY THE WA WAREHOUSE THAT THE 10MM ADAPTOR BOLT IS MISSING, AND THAT IT WAS NEVER RETURNED FROM THE HOSPITAL WHICH CONTRADICTS THE COMPLAINT OF THE ADAPTOR BOLT BEING STUCK IN THE TRIAL FEMUR. THERE HAS BEEN A COMPLETE SEARCH OF THE HOSPITAL SSD AND THE "MISSING" ADAPTOR CAN NOT BE LOCATED THERE. THE WA WAREHOUSE RECEIVABLES TEAM NEED TO DO A FULL SEARCH OF THE RETURNS AREA OR PC INSTRUMENT HOLD AREA FOR THESE PRODUCTS FOR FURTHER FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797088 ↗
• MalfunctionJan 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE 2 INSTRUMENTS GOT STUCK TOGETHER AND COULDN'T BE SEPARATED AT THE END OF SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13310853 ↗
• MalfunctionJul 12, 2021Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE PLUS 5 ADAPTER TRIAL HAS BEEN USED BEFORE AND WAS DAMAGED WHEN TRYING TO TAKE IT OUT OF THE 31MM SLEEVE TRIAL. THE METAL HAS BEEN SCRAPED UP AND THE TRIALS DON¿T FIT TOGETHER CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154810 ↗
• MalfunctionAug 30, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE METAL NEEDS TO BE SANDED DOWN. IT WAS AN OFFICE SET. DID NOT EFFECT SURGERY. INABILITY TO DISASSEMBLE MATING DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832415 ↗
• MalfunctionApr 2, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE ADAPTOR BOLT STUCK INTO SLEEVE TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7388223 ↗