LPS 1987-25-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295079170), received between Sep 22, 2017 and Mar 30, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS DISTAL FEMORAL REPLACEMENT FROM A PREVIOUSLY FAILED REV KNEE. THE FEMORAL COMPONENT BECAME LOOSE FROM THE CEMENT MANTEL AND THERE WAS A LOT OF BONE REMODELING. THE FEMORAL COMPONENT WAS REMOVED WITH EASE AND THE BONE REMODELED BONE WAS RESECTED AND ANOTHER DFR WAS IMPLANTED WITH LONGER SEGMENTS. ACTIVITY LEVEL: YES, DOI: ON (B)(6) 2021, DOR: UNKNOWN, AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 24733534 ↗
• InjuryJul 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF CEMENTED STEM AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22532133 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22100096 ↗
• InjuryJan 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE. IT WAS REPORTED THAT THE PATIENT HAD A DISTAL FEMORAL REPLACEMENT DONE IN 2002. DID WELL FOR 22 YEARS. FEMORAL COMPONENT CAME LOOSE SO REVISED THAT COMPONENT WITH A NEW INSERT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21252847 ↗
• InjuryNov 14, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAINFUL KNEE, POSSIBLY LOOSE DFR. THE STEM WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20686914 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FEMORAL NECK FRACTURE. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 12852115 ↗
• InjuryOct 13, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12624535 ↗
• InjuryAug 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANTED LPS STEM AT FEMUR HAS BEEN BROKEN. THE X-RAY SHOWED THAT THE IMPLANT AND BONE BOTH FRACTURED. DOR: (B)(6) 2021.

  Patient problems: Limb Fracture

  MAUDE report 12318719 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE UNKNOWN INTERFACE. FEMORAL COMPONENT AND INSERT WERE REMOVED. WASHED PATIENT OUT AND TRIM PLANTED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10379089 ↗
• InjuryOct 5, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE FEMORAL STEM COMPONENT AT CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 6916733 ↗
• InjurySep 22, 2017Loss of or Failure to Bond; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Improper or Incorrect Procedure or Method

  PATIENT WAS REVISED TO ADDRESS PAIN, OSTEOLYSIS AND LOOSENING OF THE FEMORAL STEM AND TIBIAL STEM AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. UPDATE 8/24/2017 AND 8/30/2017 DER AND RECORDS REVIEWED FOR REPORTABILITY. IT WAS IDENTIFIED AND CONFIRMED WITH DEPUY PRODUCT ENGINEER FOR LPS SYSTEM THAT THE USAGE OF THE LE INTRCL STR D TAIL ASSM 55MM WITH LPS CEMENTED STEM 12X125MM STR AND LPS CEM FEM STEM 13X150MM BOW AS A CONSTRUCT ACROSS THE PATIENT'S KNEE JOINT (STEM CEMENTED IN DISTAL FEMUR AND STEM CEMENTED IN PROXIMAL TIBIA, WITH THE LE INTRCL STR D TAIL ASSM 55MM BRIDGING THE KNEE JOINT) TO FUNCTIONALLY FUSE THE KNEE JOINT (SEE INCLUDED X-RAYS) IS AN OFF LABEL USE OF THESE PRODUCTS AND POSSIBLY THE REASON FOR THEIR FAILURE, REQUIRING REVISION SURGERY. COMPLAINT UPDATED ON: 9/21/2017.

  Patient problems: Osteolysis; Pain

  MAUDE report 6886713 ↗