LPS 1987-07-065Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295078562), received between Aug 6, 2019 and Jan 23, 2026 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTS WITH INFECTION POST SPACER. HOWEVER, PATIENT NOW PRESENTS WITH A FUNGAL INFECTION. ALL COMPONENTS PERFORMED AS EXPECTED AND WERE WELL FIXED, HOWEVER HAD TO BE REMOVED TO TREAT THIS NEW FINDING. ALL COMPONENTS WERE SUCCESSFULLY REMOVED, AND AFTER A THOROUGH DEBRIDEMENT, THE BONE WAS PREPARED FOR NEW COMPONENTS. DURING DEBRIDEMENT, A VESSEL WAS PERFORATED DUE TO SCAR TISSUE AND WAS REPAIRED OPERATIVELY. THE SURGEON STATED THIS TO BE A COMMON OCCURRENCE DUE TO THE LOCATION OF DEBRIDEMENT ANATOMICALLY AND WAS EXPECTED AND PREPARED FOR. THIS RESULTED IN A SHORT DELAY WHILE THE REPAIR TOOK PLACE. NEW COMPONENTS WERE PLACED UNEVENTFULLY FOR A NEW SPACER, ALONG WITH PLACEMENT OF ANTIBIOTIC BEADS, ANTIFUNGAL BEADS AND HIGH DOSE ANTIBIOTIC CEMENT. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 24164547 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DESPITE REPEATED ATTEMPTS TO CURE THE SYSTEMIC INFECTION THIS PATIENT HAD, PATIENT CONTINUED TO SHOW INFECTION AND IT WAS DECIDED TO REMOVE THE IMPLANTS IN HIS RIGHT LEG AND PERFORM AN ABOVE KNEE AMPUTATION. ALL COMPONENTS PERFORMED AS EXPECTED TO THERE WAS NO ALLEGATION AGAINST THE COMPONENTS. THIS SUBMISSION IS BEING MADE AS THE IMPLANTS WERE REMOVED. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 22688972 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS INFECTION AND ALL COMPONENTS WERE REMOVED AND A SPACER WAS MADE WITH NEW COMPONENTS. HIGH DOSE ANTIBIOTICS WERE PLACED ON COMPONENTS ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. HICKMAN CATHETERS WERE ALSO PLACED TO PROVIDE ADDITION ANTIBIOTIC TREATMENT POSTOPERATIVELY. NO PATIENT HARM WAS NOTED AND NO DELAY OCCURRED. INITIAL PROCEDURE FEMORAL SIDE COMPONENTS WERE REVISED ON (B)(6) 2024. A I&D WITH FEMUR AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2025 AND (B)(4) WAS SUBMITTED. THERE WAS A LOOSENING REPORTED AT STEM ON BONE TO CEMENT INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22373109 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DISLOCATED AGAIN FROM A COMPETITIVE CONSTRAINED LINER. SURGEON CHOOSE TO REMOVE THE COMPETITIVE CUP AND PLACE A DEPUY CUP AND CONSTRAINED LINER. UNFORTUNATELY, AFTER BEING REPEATED FAILURES WITH THE COMPETITIVE LINER THE SURGEON HAD STRONG SUSPICION OF INFECTION DUE TO ELEVATED LABS AND CHOSE TO CHANGE ALL MODULAR COMPONENTS AND PLACE RESORBABLE ANTIBIOTIC BEADS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19215837 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE AFFECTED SIDE INVOLVED FOR LPS TOTAL FEM SEG COMP 55MM(B)(4) THIS PRODUCT? LEFT OR RIGHT? B. WHAT IS THE DEFICIENCY/ALLEGATION AGAINST THE REPORTED PRODUCT? C. CAN YOU CONFIRM IMPLANTS INVOLVED IN THE EVENT WERE NOT FROM DEPUY? ANSWERS: A. ALL ITEMS WERE LEFT SIDE. B. NONE, JUST REMOVED AND REPLACED. C. YES, NO ALLEGATION NOR DEFICIENCY ON DEPUY-RELATED PRODUCTS, THEIR INVOLVEMENT WAS ONLY RELATED AS THEY WERE PLACED INTO THE FAILED COMPETITIVE COMPONENT WHICH FAILED.

  Patient problems: Joint Laxity

  MAUDE report 19126519 ↗
• InjurySep 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SURGERIES TOOK PLACE PRIOR TO THIS CASE UTILIZING JNJ IMPLANTS, 9-30-2020 WITH THE FIRST SURGEON AT THE HOSPITAL, AND THEN AT ANOTHER HOSPITAL WITH THE ANOTHER SURGEON ON (B)(6) 2021. THE INITIAL CASE WITH THE FIRST SURGEON WAS A TOTAL FEMUR FOR TREATMENT OF CHRONIC INFECTION. THE OTHER SURGEON THEN CONVERTED THE TOTAL FEMUR TO A KNEE FUSION AS HER QUAD MECHANISM FAILED. ULTIMATELY THE PATIENT HAD A HIP DISARTICULATION ON (B)(6) 2022 AS THE INFECTION RESURFACED. A DER WAS SUBMITTED WHEN THE SECOND SURGEON PERFORMED HIS PROCEDURE. NO PT HARM WAS CREATED BY JNJ IMPLANTS. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15397922 ↗
• InjurySep 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SURGERIES TOOK PLACE PRIOR TO THIS CASE UTILIZING JNJ IMPLANTS, (B)(6) 2020 WITH THE FIRST SURGEON AT THE HOSPITAL, AND THEN AT ANOTHER HOSPITAL WITH THE ANOTHER SURGEON ON (B)(6) 2021. THE INITIAL CASE WITH THE FIRST SURGEON WAS A TOTAL FEMUR FOR TREATMENT OF CHRONIC INFECTION. THE OTHER SURGEON THEN CONVERTED THE TOTAL FEMUR TO A KNEE FUSION AS HER QUAD MECHANISM FAILED. ULTIMATELY THE PATIENT HAD A HIP DISARTICULATION ON (B)(6) 2022 AS THE INFECTION RESURFACED. A DER WAS SUBMITTED WHEN THE SECOND SURGEON PERFORMED HIS PROCEDURE. NO PT HARM WAS CREATED BY JNJ IMPLANTS. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2020 DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15397673 ↗
• InjurySep 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SURGERIES TOOK PLACE PRIOR TO THIS CASE UTILIZING JNJ IMPLANTS, (B)(6) 2020 WITH THE FIRST SURGEON AT THE HOSPITAL, AND THEN AT ANOTHER HOSPITAL WITH THE ANOTHER SURGEON ON (B)(6) 2021. THE INITIAL CASE WITH THE FIRST SURGEON WAS A TOTAL FEMUR FOR TREATMENT OF CHRONIC INFECTION. THE OTHER SURGEON THEN CONVERTED THE TOTAL FEMUR TO A KNEE FUSION AS HER QUAD MECHANISM FAILED. ULTIMATELY THE PATIENT HAD A HIP DISARTICULATION ON (B)(6) 2022 AS THE INFECTION RESURFACED. A DER WAS SUBMITTED WHEN THE SECOND SURGEON PERFORMED HIS PROCEDURE. NO PT HARM WAS CREATED BY JNJ IMPLANTS. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15397671 ↗
• InjuryFeb 17, 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: (B)(6) 2013. DOR: (B)(6) 2013. AFFECTED SIDE: LEFT.

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

  MAUDE report 13548790 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO DRAIN. ALL COMPONENTS WERE REMOVED AND REPLACED IN A SINGLE STAGE REVISION UTILIZING A DUAL SET UP. THE CEMENT WAS A DEPUY PRODUCT BUT THE INFORMATION WAS NOT AVAILABLE AS IT WAS A HOSPITAL OWNED INVENTORY AND NOT ON THE PAPERWORK. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 13168150 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH A DRAINING WOUND. SURGEON SUSPECTS INFECTION AND FINDS PUSS IN THE KNEE. SURGEON PERFORMS A ONE STAGE KNEE REVISION WITH A DUAL SET UP AND PLACEMENT OF ANTIBIOTIC BEADS. TWO SURGERY DATES RELATE TO THIS DER AS A POLY EXCHANGE WAS PERFORMED ON (B)(6) 2021 WHERE A DER WAS SUBMITTED. CEMENT UTILIZED WAS A DEPUY PRODUCT, HOWEVER PART AND LOT INFO ARE UNAVAILABLE AS IT IS HOSPITAL OWNED AND NOT ON A PAPERWORK. DOI: (B)(6) 2021. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 12923037 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS REMOVED WERE INSERTED ON (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2021. DER HAVE BEEN SUBMITTED ON EACH OF THESE DATES WITH RESPECTIVE CHANGES. ULTIMATELY THE GRAFT THAT WAS PLACED IN THE PATIENT BECAME INFECTED AND ALL IMPLANTS WERE REMOVED. ANTIBIOTIC BEADS AND A SPACER WAS PLACED IN THE PATIENT. NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2021 (TIBIAL TRAY, TIBIAL STEM, TIBIAL SLEEVE, AND CONTROL CABLE); DOI: (B)(6) 2021 (DISTAL FEMORAL COMPONENT, AND FEMORAL STEM); DOI: (B)(6) 2021 (FEMORAL SEGMENTAL COMPONENTS, AND TIBIAL INSERT); DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11602855 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD WOUND DEHISCENCE. THE SURGEON PERFORMED A THOROUGH I&D WITH COMPONENT EXCHANGE. DOI: (B)(6) 2020. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 10830232 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO REPORTED THAT THE LPS DISTAL FEMUR WAS REMOVED DUE TO PATELLA TRACKING ISSUES RESULTING IN PATELLA ALTA. IMPLANTS WERE REMOVED AND SEGMENTS SHORTENED FROM A 65MM TO A 50MM CONSTRUCT TO RISE THE JOINTLINE AND REMEDY THE ISSUE. ALSO, AN INFECTION WAS PRESENT AND APPROPRIATE STEPS WERE TAKEN TO ERADICATE. DOI: UNKNOWN. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10026574 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A INFECTED LEFT KNEE. LPS POLY INSERT WAS EXCHANGED. WASH OUT AND I&D WERE PERFORMED IT WAS REPORTED AT (B)(4). REVISED REPORT: PATIENT WENT ON TO HAVE A LEFT ABOVE KNEE AMPUTATION. ADDING IMPLANTS TO REPORT THAT WERE TAKEN OUT AT TIME OF AMPUTATION ON (B)(6) 2019. THESE WERE ORIGINALLY IMPLANTED (B)(6) 2019. DOI: (B)(6) 2019, (LPS UNIV TIB HIN INS XSM 16 MM). DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8864558 ↗