LPS 1987-07-085Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295078579), received between Jan 29, 2018 and Jun 25, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO DRAIN FROM KNEE WOUND. SURGEON ELECTED TO REMOVE KNEE PROSTHESIS AND FUSE THE KNEE. THIS COMPLAINT (B)(4). DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22329546 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO DRAIN POST REVISION TKA. SURGEON CHOSE TO REMOVE ALL MODULAR COMPONENTS AND PERFORM THOROUGH I&D. CULTURES WERE TAKEN TO RULE OUT INFECTION. TISSUES LOOKED SATISFACTORY AND LABS HAVE NORMALIZED. NO DELAY NOR PATIENT HARM OCCURRED. THERE IS NO ALLEGATION AGAINST COMPONENTS, SIMPLY EXCHANGED AS DRAINAGE THIS FAR POST REVISION COULD BE DUE TO A POTENTIAL INFECTION, ESPECIALLY WITH HER PREVIOUS HISTORY OF INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 20322382 ↗
• 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: ON (B)(6) 2022, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19239069 ↗
• 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 13357983 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH PAIN IN FEMUR AND X-RAYS SHOW WHAT APPEARS TO BE A LOOSE FEMORAL SLEEVE. PATIENT IS TAKEN TO OR TO REVISE FEMORAL IMPLANT WITH SUSPICION OF INFECTION DUE TO HIS REPEATED INFECTION HISTORY. FROZEN SECTION SHOWED 7 WHITE CELLS PER HPF. SURGEON CHOSE TO REMOVE ALL COMPONENTS AND REPLACE THE KNEE IN A ONE STAGE REVISION UTILIZING A DUAL STAGE SET UP. ANTIBIOTIC BEADS WERE PLACED IN ADDITION TO COATING THE NON ARTICULATING PORTION OF THE COMPONENT WITH HIGH DOES ANTIBIOTIC CEMENT. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12779145 ↗
• InjuryAug 17, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A SPACER MADE OF LPS IMPLANT TO TREAT CHRONIC INFECTION. SEGMENTS DISASSOCIATED AND PATIENT WAS BROUGHT TO OR. A THROUGH I&D WAS PERFORMED. SEGMENTS WERE DRIED AND IMPACTED TOGETHER. MANY ATTEMPT TO SEPARATE THE SEGMENTS WERE PERFORMED WITH NO MOVE TO AT ANY JUNCTION. ANTIBIOTIC BEADS WERE PLACED AND PATIENT WAS CLOSED UNEVENTFULLY. THE DISASSOCIATION OCCURRED BETWEEN THE LISTED SEGMENTS. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12330649 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD REPEATED REVISIONS AND COMPONENT EXCHANGES FOR INFECTION INVOLVING DEPUY PRODUCTS.

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

  MAUDE report 12263642 ↗
• InjuryApr 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SEGMENTS SEPARATED AT JUNCTION, SO DOCTOR TOOK ALL SEGMENTS OUT AND USED A 35 INSTEAD OF 30 TO ADD LENGTH. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

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

  MAUDE report 11656715 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED TOTAL KNEE. SURGEON REMOVED ONLY THE DISTAL FEMUR PARTS AND INSERT AND PERFORMED AN IRRIGATION AND DEBRIDEMENT AND REPLACED THE PARTS WITH THE SAME IMPLANTS THAT WERE REMOVED. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10638582 ↗
• InjuryMay 30, 2019Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  LPS FEMORAL COMPONENTS REVISED DUE TO THE STEM BECOMING LOOSE AND THE FEMORAL COMPONENT ROTATING.

  Patient problems: No Code Available

  MAUDE report 8653555 ↗
• InjuryJan 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS POTENTIAL INFECTION AND PAIN. THE SURGEON AND PT CHOSE TO AMPUTATE LEG. ALL COMPONENTS REMOVED. NO INSTRUMENTATION BROKE DURING CASE. PRIOR SURGERY WITH TIBIAL SIDE IMPLANTED WAS DONE DIFFERENT TIME, DO NOT HAVE INFORMATION OR PRODUCT NUMBERS. (B)(6) 2015; (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7224581 ↗