LPS 1987-27-321Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295079613), received between Jan 3, 2018 and Jul 25, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PROXIMAL TIBIAL REPLACEMENT SURGERY DUE TO BONE CANCER 14 YEARS AGO. SURGEON DID A POLY SWAP, HINGE PIN, AND BUMPER EXCHANGE IN 2018. SURGEON PERFORMED ANOTHER POLY SWAP HINGE PIN AND BUMPER EXCHANGE AGAIN (B)(6) 2024 DUE TO INSTABILITY OF THE KNEE. IT WAS THOUGHT THAT SOMETHING BECAME LOOSE IN THE KNEE. UPON INSPECTION OF THE INSERT IT LOOKED AS IF THE METAL POST IN THE INSERT WAS SLIGHTLY TOGGLING BUT WAS INCONCLUSIVE IF THE BEARING HAD BROKEN WITHIN THE INSERT. DOI: ON (B)(6) 2018. DOR: ON (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19827879 ↗
• MalfunctionOct 20, 2021Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  THE PARCEL WAS BROKEN IN THE FOIL. NO ISSUES WITH THE OUTER BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668971 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2004, THE PATIENT UNDERWENT A BILATERAL KNEE ARTHROPLASTY DUE TO ARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED IN BOTH KNEES. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2011, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, COMPARTMENT SYNDROME, DISLOCATION, INSTABILITY, AND ABSCESS. ALL COMPONENTS WERE NOTED TO BE REMOVED AND REPLACED WITH ARTICULATING ANTIBIOTIC SPACER. UNKNOWN MANUFACTURER PRODUCTS WERE IMPLANTED DURING THE REVISION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation; Joint Laxity

  MAUDE report 11334434 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. I&D WAS PERFORMED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9401695 ↗
• InjuryApr 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  SURGEON REPORTED TO BFARM: PRIMARY KNEE TEP-LEFT SIDE ON 2002. AFTER TRAUMA/FRACTURE CHANGE IN (B)(6) 2007. TIBIAL CHANGE AFTER LOOSENING IN (B)(6) 2011. CHANGE OF FEMORAL COMPONENTS AFTER FRACTURE IN 2014. IN MID OF (B)(6) 2017 PATIENT REPORTED A SUDDEN PAIN WHILE TREADING. SINCE THIS MOBILISATION WITH HELP OF CRUTCH, ANALGESIA WITH INDOMETACIN. X-RAY SHOWED FRACTURE OF TIBIA AND DISLOCATION. REVISION ON (B)(6) 2017. DOI: 2014; DOR: (B)(6) 2017; LEFT KNEE.

  Patient problems: Bone Fracture(s); Joint Dislocation; Not Applicable; Pain

  MAUDE report 7411561 ↗
• InjuryJan 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOE: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7159997 ↗