LPS 1987-07-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295078524), received between Nov 10, 2017 and May 15, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WOUND BREAKDOWN POST MULTIPLE REVISION TKA LEADING TO POTENTIAL CONTAMINATION OF THEIR PROSTHESES. THE SURGEON CHOSE TO REMOVAL ALL WELL FIXED AND WELL FUNCTIONING COMPONENTS AND PLACE A STATIC SPACER FASHIONED WITH LPS COMPONENTS WITHOUT DELAY NOR PATIENT HARM. A GASTROC FLAP WAS PERFORMED BY THE PLASTIC SURGEON POST SPACER PLACEMENT IN HOPES OF HEALING THIS WOUND. THIS PATIENT HAS HAD MULTIPLE SURGERIES SINCE THIS DATE TO ADDRESS COMPLICATIONS WITH IMPLANTS BEING EXCHANGED. THE DATES WERE AND THE DER NUMBERS ARE LISTED (B)(6) 2026 (B)(6), (B)(6) 2026 ,(B)(6) ,(B)(6)2026 (B)(6). DOI: (B)(6) 2026 DOR: (B)(6) 2026 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 25192766 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REMOVING A PROXIMAL TIBIAL REPLACEMENT DUE TO CEMENTED STEM FRACTURE BREAK. UPON REMOVAL THE SURGEON INDICATED AN INCREASED AMOUNT OF POLYETHYLENE WEAR WHICH IN TURN CREATED METALOSIS IN THE JOINT. THE SURGEON BELIEVES THE POLY WEAR MAY HAVE LEAD TO THE FAILURE. DOI: (B)(6) 2015, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction

  MAUDE report 24429432 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS VERY SICK AND HAS FULL BODY INFECTION. PATIENT PRESENTED WITH BILATERAL KNEE AND SHOULDER INFECTIONS IN (B)(6) 2025 AND SURGEON WAS DOING EVERYTHING HE CAN TO CLEAR THE INFECTION. SURGEON ELECTED TO REMOVE DFR IMPLANT AND FUSE KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24051357 ↗
• InjuryNov 5, 2025Adverse 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. THE SPACER AND ALL CEMENT ARE REMOVED. A THOROUGH I&D IS PERFORMED AND A NEW SPACER IS FASHIONED UTILIZING LPS COMPONENTS. NO PATIENT HARM NOR DELAY WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23477256 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO DRAIN AFTER HER PROCEDURE. LABS LOOK GOOD AND ASPIRATION IS NEGATIVE FOR INFECTION. SURGEON BELIEVES THE ANTIBIOTICS PLACED A THE TIME OF SURGERY ARE CAUSING THE DRAINAGE, SO HE CHOSE TO REMOVE ALL COMPONENTS AND PLACE NEW ONES. NO DELAY NOR PATIENT HARM IS NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THEY WERE FUNCTIONING AS EXPECTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 22441261 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION OF A LEFT KNEE DISTAL FEMORAL REPLACEMENT. SURGEON REMOVED CERTAIN IMPLANTS AND PERFORMED I&D AND WASHOUT AND REPLACED IMPLANTS ALONG ANTIBIOTIC CEMENT. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21549784 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DRAINING, SURGEON ELECTED TO WASHOUT AND CHANGE MODULAR PARTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 20353286 ↗
• 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 20322481 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNABLE TO STRAIGHTEN LEG. SO SURGEON REVISED THE MODULAR COMPONENTS. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19974361 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO.

  Patient problems: Joint Laxity; Physical Asymmetry

  MAUDE report 19286552 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND SUSTAINED A SOFT TISSUE INJURY AFTER THE FIRST SURGERY AND DFR. DURING THIS FALL, SURGEON SUSPECTS THAT THE PREVIOUSLY SUTURED SOFT TISSUE ENVELOPE BECAME BROKEN CAUSING THE PATELLA TO BECOME DISLOCATED LATERALLY. BY THE TIME THE SURGERY WAS SCHEDULED, THE PATELLA TENDON AND ALL THE SOFT TISSUES WERE SCARRED DOWN AND MADE THE PATELLA TRACK LATERALLY AND INHIBITED THEIR RANGE OF MOTION. IN ORDER TO HELP WITH THIS, THE SURGEON DECIDED TO REMOVE THE DISTAL FEMORAL COMPONENT IN ORDER TO EXTERNALLY ROTATE THE FEMUR AND HELP WITH THE LIMITED PATELLA FUNCTION AND OVERALL RANGE OF MOTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Fall; Joint Laxity; Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 17818605 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STILL DRAINING AND SURGEON ELECTED TO WASH OUT AND CHANGE COMPONENTS THAT HE WAS ABLE TO. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 16417861 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS 2 STAGE INFECTION WAS REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Fluid Discharge; Loss of Range of Motion; Necrosis; Pain; Unspecified Infection

  MAUDE report 13533876 ↗
• 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 WAS BEING TREATED FOR INFECTION. SO, WHETHER THE INFECTION HAD CLEARED SINCE THE DATE OF SURGERY WOULD BE UNLIKELY. HOWEVER, THIS WAS NOT A NEW INFECTION, IT WAS A RECURRENT INFECTION THAT HAS BEEN BEING TREATED FOR YEARS. THE REASON FOR EXCHANGING THE COMPONENTS WAS CONTAMINATION DUE TO THE IMPLANT PERFORATING HIS SKIN.

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

  MAUDE report 12263641 ↗
• 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 11656727 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS PREVIOUS DATES OF SURGERY AS FOLLOWS: (B)(6) 2019 (PRIMARY IMPLANTATION), (B)(6) 2020 (FIRST REVISION), (B)(6) 2021 (POLY INSERT REVISION) AND (B)(6) 2021 (THIRD REVISION. HARDWARE WAS PLACED AND OR EXCHANGED ON THESE DATES. DER'S WERE SUBMITTED EACH TIME. PATIENT HAD RETURNED HOME AND WAS DOING WELL. PATIENT HAS A BAD FALL AND LACERATED HIS KNEE TRANSVERSELY. PATIENT WAS TREATED AT ANOTHER FACILITY. AFTER A FEW WEEKS PATIENT WAS BROUGHT TO THE ER BY HIS DAUGHTER WERE PATIENT WAS SEEN AND HAD AN OPEN WOUND. SURGEON BELIEVED THERE WAS GROSS CONTAMINATION OF THE JOINT AND CHOSE TO REMOVE ALL COMPONENTS. A NEW SPACER WAS PLACED AND DEPUY CEMENT WAS USED BUT IT IS HOSPITAL OWNED SO DO NOT HAVE PART OR LOT INFORMATION. DOI: (B)(6) 2019 (PRIMARY IMPLANTATION), (B)(6) 2020 (FIRST REVISION), (B)(6) 2021 (POLY INSERT REVISION), (B)(6) 2021 (THIRD REVISION). DOR: (B)(6) 2021, RIGHT KNEE. THIS REPORT CAPTURES THE EVENT AND PRODUCTS INVOLVED FOR (B)(6) 2021.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Laceration(s); Wound Dehiscence

  MAUDE report 11437199 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S QUAD TENDON WAS RUPTURED AND SO UPON REPAIR THESE IMPLANTS WERE REPLACED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11247111 ↗
• InjuryAug 14, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED DUE TO FALL AND LOOSENING OF THE FEMUR & STEM COMPONENT AT THE BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER USED WAS UNKNOWN. PATIENT HAD LPS IMPLANTED IN (B)(6) 2019. PATIENT WAS REVISED USING CEMENTED LPS STEM. DOI: (B)(6) 2019 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10410554 ↗
• InjurySep 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7862067 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES CHRONICALLY INFECTED AND RECURRENTLY DISLOCATED LPS PROXIMAL FEMUR TOTAL HIP. IRRIGATION AND DEBRIDEMENT WITH EXCHANGE OF COMPONENTS AND CONVERSION TO A CONSTRAINED LINER. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7641376 ↗
• 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 7224664 ↗
• InjuryNov 14, 2017Loss of Osseointegration; Loss of Osseointegration

  DER STATES PT COMPLAINED OF THIGH PAIN AND INSTABILITY WITH POOR QUAD FUNCTION AND PATELLA TRACKING. INSTABILITY NOTED AT ROUGHLY 20 DEG FLEXION. FROZEN SECTION AND LABS NOT INDICATIVE OF INFECTION. FEMORAL SLEEVE WAS NOT INGROWN AND WAS RE-PREPARED AND REPLACED. TIBIAL AND STEM WERE ALSO REMOVED AND REPLACED, BUT SLEEVE WAS FOUND TO BE INGROWN AND WELL FIXED. A PATELLAR TENDON ALLOGRAFT WAS USED. IT ALSO STATES LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO IMPLANT INTERFACE.

  Patient problems: Pain

  MAUDE report 7029281 ↗
• InjuryNov 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF FEMORAL STEM AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7017426 ↗