LPS 1987-25-415Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295079200), received between Mar 20, 2019 and Mar 13, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO THE FEMORAL CONSTRUCT LOOSENED/BROKE FREE FROM CEMENT MANTLE. THE LOOSENING INTERFACE IS CEMENT TO IMPLANT. CEMENT USED IS OF DEPUY. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 21599587 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FRACTURED PERIPROSTHETIC. LPS DISTAL FEMUR INSITU - PT FALL AND FRACTURE. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Fall; Limb Fracture; Pain

  MAUDE report 12440163 ↗
• 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 11602842 ↗
• InjuryMay 5, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  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 JOINT LINE 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 10026569 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT SLIPPED ON THE TILE AT HER HOME AND FELL TO THE SIDE. SHE DID NOT STRIKE HER HEAD OR LOSE CONSCIOUSNESS. PATIENT SUFFERED A RIGHT FEMUR FRACTURE PER IMAGING. IMG TO CONSULT FOR PERIOPERATIVE MEDICAL RISK STRATIFICATION. PATIENT DENIES ANY CHEST PAIN, DYSPNEA, N/V/D, HEADACHE. ON (B)(6) 2018, THE PATIENT UNDERWENT ORIF OF A RIGHT PERIPROSTHETIC FEMUR FRACTURE. POSTOPERATIVELY, 2-1/2 WEEKS, THE PATIENT COMPLAINS OF BURNING AND SWELLING AROUND THE RIGHT KNEE AND TOWARDS THE RIGHT LOWER EXTREMITY. ON (B)(6) 2018, THE PATIENT REPORTS THAT SHE WAS PERFORMING PASSIVE LEG RAISES AT HOME AND FELT SOMETHING BREAK AT HER PREVIOUS SURGICAL SITE. THE PATIENT IS S/P ORIF RIGHT DISTAL FEMUR PERIPROSTHETIC FRACTURE. PAIN WAS SHARP, NON-RADIATING AND RATED 10/10. ON (B)(6) 2018, THE PATIENT COMPLAINS LEFT LEG PAIN THAT STARTED SUDDENLY. SHE WAS DOING EXERCISE WITH PT AT HOME AND SHE WAS FOUND TO HAVE FRACTURED HARDWARE. ON (B)(6) 2019, PATIENT WITH UNFORTUNATE NONUNION. SHE HAS BROKEN HER HARDWARE. SHE HAS FAILED HARDWARE AND A FAILED TOTAL KNEE ARTHROPLASTY AND ESSENTIALLY A DEFORMITY OF THE KNEE W/ A PAINFUL RIGHT LEG. SHE WAS ADMITTED URGENTLY BEC

  Patient problems: Edema; No Code Available; Pain; Wound Dehiscence

  MAUDE report 9693485 ↗
• InjuryMar 20, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT AS USED. IT WAS REPORTED THAT THE LOOSENING WAS CAUSED BY PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2017, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8437609 ↗