LPS 1987-07-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295078586), received between Nov 13, 2018 and May 3, 2024 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO BE INFECTED. SURGEON PERFORMS A THOROUGH I&D AND MODULAR COMPONENT EXCHANGE IN HOPES TO CLEAR UP. NO PATIENT HARM OCCURRED NOR DELAY WAS EXPERIENCED. NO LOT INFORMATION WAS AVAILABLE DUE TO TRANSITION TO OPTIMIZE. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19239081 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT COMES INTO EMERGENCY ROOM AND WITH PAIN AND NOT FEELING WELL. XRAYS SHOW HETEROTOPIC BONE FORMATION AND WHAT APPEARS TO BE GAS IN TISSUES SURROUNDING THE IMPLANT, SIGNIFYING INFECTION. ONCE OPENED, GROSS PUS WAS NOTED CONFIRMING INFECTION. A THOROUGH I&D WITH REMOVAL OF HETEROTOPIC BONE, EXCHANGE OF COMPONENTS, PLACEMENT OF ANTIBIOTIC BEADS AND COATING OF PROSTHESES WITH HIGH DOSE ANTIBIOTIC CEMENT IS PERFORMED. CEMENT WAS LIKELY GMV WITH GENT BUT WOULD HAVE BEEN HOSPITAL OWNED SO NO LOT INFO OR CONFIRMATION IS AVAILABLE IN MY RECORDS. NO PATIENT HARM OCCURRED. THIS PATIENT DOES HAVE MULTIPLE SIGNIFICANT COMORBIDITIES WHICH MAKE HER MORE PRONE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Extraskeletal ossification; Pain; Unspecified Infection

  MAUDE report 16195592 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. INFECTION DEVELOPED FOLLOWING TKA. THE SURGEON STATED KNEE IS STILL INFECTED AND ELECTED TO REMOVE ALL IMPLANTS AND INSERT AN ANTIBIOTIC SPACER TO ADDRESS THE ISSUE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13536188 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STILL PRESENTING SIGNS OF INFECTION. SURGEON DECIDED TO PERFORM A WASH OUT AND REMOVE IMPLANTS AND REPLACED WITH NEW IMPLANTS. THERE WERE NO INSTRUMENTS BROKEN AND NO SURGICAL TIME ADDED TO CASE. THERE WAS NO NEW INFORMATION THAT THE SALES REP CAN PROVIDE. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13357990 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION. THE PATIENT WENT THROUGH SEVERAL I&DS AND WOULD NOT GET BETTER. THE SURGEON DECIDED TO DO A HIP DISARTICULATION. THE STEM, LINER AND CUP HAD TO COME OUT. THERE WERE NO INSTRUMENTS BROKEN OR DAMAGED. ALL COMPONENTS WERE REMOVED. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12517274 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO OR DUE TO NON-HEALING WOUNDS POST-TREATMENT FOR RECURRENT INFECTION. MODULAR COMPONENTS WERE EXCHANGED, ANTIBIOTIC AND ANTIFUNGAL BEADS WERE PLACED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Impaired Healing

  MAUDE report 12354140 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. LPS SEGMENT WAS TAKEN OUT AND REPLACED WITH TWO SHORTER SEGMENTS. NO OTHER INFORMATION AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2019; UNKNOWN HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8359077 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8063835 ↗