LPS 1987-25-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295079163), received between Feb 28, 2020 and Jul 21, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 16, 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.

• InjuryJul 21, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT LOOSE DFR COMPONENT. IT WAS STATED THAT FEMORAL COMPONENT WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. CEMENT MANUFACTURER WAS MARKED AS COMPETITOR. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25887668 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2024. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19840909 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT FELL AND FRACTURED HIS DISTAL FEMUR BETWEEN HIS HINGED KNEE REPLACEMENT AND HIS PROXIMAL FEMORAL REPLACEMENT. WITH LITTLE BONE TO GAIN FIXATION BETWEEN THE IMPLANTS, THE SURGEON CHOSE TO CONVERT TO A TOTAL FEMUR. THE SURGERY WAS UNEVENTFUL AND NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 16484890 ↗
• InjuryApr 20, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE FEMORAL CONSTRUCT OF DFR COMPONENTS LOOSENED FOR UNKNOWN REASONS. POSSIBLE COMPROMISED CEMENT. REMOVED ENTIRE FEMUR IMPLANT CONSTRUCT AND INSERT AND REPLACED DISTAL FEMUR, STEM, AND INSERT. UNKNOWN IF ANY SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14160268 ↗
• MalfunctionFeb 28, 2020Tear, 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

  INTERNAL PACKAGING HAD HOLE IN WRAPPING AND SURGEON WAS CONCERNED ABOUT INTEGRITY OF STERILITY. OPENED A NEW IMPLANT AND PLACED THE OTHER ONE OFF THE FIELD. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771475 ↗