LPS 1987-17-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295078975), received between Mar 4, 2019 and Apr 22, 2025 — classified as 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER IN (B)(6) 2025 WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. NO INFORMATION WAS AVAILABLE WITH REGARD TO PRODUCTS EXPLANTED ON (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. NO INFORMATION AVAILABLE WITH REGARD TO PRODUCTS EXPLANTED ON (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND P

  Patient problems: Unspecified Infection

  MAUDE report 21883143 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT FILLED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT(CER)FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS IMPLANTED WITH DEPUY SYN (46) HIP COHORT -INVOLVING PROXIMAL FEMORAL BODY IMPLANT . (72) KNEE COHORT-INVOLVING DISTAL FEMUR IMPLANT. (13) TOTAL -INVOLVING BOTH PROXIMAL AND DISTAL IMPLANTS. (72) NONE-NOT REQUIRING THE PROXIMAL OR DISTAL IMPLANT. COMPLICATIONS SUSTAINED WITHIN 5 YEAR REVIEW: 53 PATIENTS SUSTAINED A SUBSEQUENT SURGERY AFTER THE PRIMARY IMPLANTATION OF LPS PRODUCTS. 76 PATIENTS HAD AN INFECTION AFTER THE PRIMARY IMPLANTATION OF LPS PRODUCTS. 75 PATIENTS HAD A MECHANICAL COMPLICATION AFTER THE PRIMARY IMPLANTATION OF LPS PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 14083788 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RUPTURED HER QUADRICEPS TENDON IN (B)(6) 2020. EXTENSOR MECHANISM REPAIR PERFORMED ON (B)(6) 2021. NO PRODUCTS WERE REVISED. DOI: (B)(6) 2020, DOE: (B)(6) 2020, DOE: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11358843 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DFR DONE ON (B)(6) 2020. SHE RUPTURED HER QUADRICEPS TENDON IN (B)(6) 2020 AND NOW HAD AN INFECTION. THE INSERT, POLY BUTTON AND HINGE PIN WERE REMOVED. THE JOINT WAS WASHED AND SCRUBBED THEN A NEW INSERT, POLY BUTTON AND HINGE PIN WERE IMPLANTED. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscle/Tendon Damage

  MAUDE report 11253184 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2018; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8386220 ↗