LPS 2987-14-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295157830), received between Jan 10, 2019 and Nov 15, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 4 most recent of 4 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) IN (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 15797070 ↗
• MalfunctionJul 23, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  QUESTION: 1. PLEASE CLARIFY WHAT YOU MEAN BY DAMAGE? IS IT CRACKED? BENT? STRIPPED OR ETC? 2. THE DER IS MARKED "ALL PARTS WERE RETRIEVED". FOR PIECES BEING RETRIEVED FROM PATIENT. PLEASE VERIFY IF THIS WAS MARKED BY MISTAKE OR THE INSTRUMENT BROKE AND WAS LEFT IN THE PATIENT? ANSWERS FOR YOUR QUESTION: 1. THE INNER PIECE OF THE FEMUR, WHERE THE HINGE PIN SLIDES THROUGH HAD BEEN DEFORMED IN SOME WAY. THE PIN WOULD NOT SLIDE THROUGH. 2. THE INITIAL TRIALS WERE NOT BROKEN INTO PIECES. BY SAYING THAT ALL PARTS WERE RETRIEVED. I AM SAYING, THAT ALL THE DAMAGED TRIALS WERE RECEIVED. AND SENT TO OUR CINCINNATI OFFICE. NOTHING WAS BROKEN OFF INTO MULTIPLE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221109 ↗
• MalfunctionFeb 21, 2019Break; Break

  IT WAS REPORTED THAT THE SPRING INSIDE OF TRIAL BROKE IN TWO AND CAME OUT DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358400 ↗
• MalfunctionJan 10, 2019Material Twisted/Bent; Material Twisted/Bent

  SPRING IS BENT AND TRIALS ARE NOT ABLE TO BE PUT TOGETHER PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235446 ↗