LPS 1987-25-413Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295079187), received between Sep 13, 2021 and Apr 25, 2025 — classified as 6 injuries, 1 malfunction.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. FEMUR WAS REMOVED AND REPLACED WITH NEW ONE. THERE WAS NO BROKEN INSTRUMENT NOR ANY SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 21908364 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRODUCT IS SUBLICATING. THE PATIENT IS IN A LOT OF PAIN. THIS HAPPENS WHEN SHE SITS OR STANDS. THE DOCTOR CAN FILL IT AND IT MAKES A POPPING NOISE. SHE DOES POP IT BACK IN. PATIENT SHATTERED THE LOWER FEMUR ON HER LEFT LEG AT THE POINT WHERE IT MET HER ARTIFICIAL KNEE. SINCE THAT TIME, THE PATIENT HAS HAD MULTIPLE "PARTIAL DISLOCATIONS" WHERE THE KNEE FEELS LIKE IT POPS OUT AND THEN HAS TO BE PUSHED BACK INTO PLACE. AFFECTED SIDE: LEFT. DOI: (B)(6) 2022.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21445389 ↗
• MalfunctionJun 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT STATED THAT ON (B)(6) 2023 THE PATIENT HAD A COMPLEX LEFT KNEE REVISION WITH REMOVAL OF UNKNOWN MANUFACTURED PRODUCTS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. SINCE THAT TIME, THE PATIENT HAS BEEN EXPERIENCING PAIN, AND A SENSATION OF KNEE LOCKING UP/ROTATING. THE PATIENT SAW A SURGEON WHO NOTED THAT THERE WAS A FAILED JUNCTION ALLOWING THE FEMORAL STEM TO ROTATE. DOI: (B)(6) 2023 , DOR: UNKNOWN (LEFT KNEE).

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 19613290 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND SUSTAINED A SOFT TISSUE INJURY AFTER THE FIRST SURGERY AND DFR. DURING THIS FALL, SURGEON SUSPECTS THAT THE PREVIOUSLY SUTURED SOFT TISSUE ENVELOPE BECAME BROKEN CAUSING THE PATELLA TO BECOME DISLOCATED LATERALLY. BY THE TIME THE SURGERY WAS SCHEDULED, THE PATELLA TENDON AND ALL THE SOFT TISSUES WERE SCARRED DOWN AND MADE THE PATELLA TRACK LATERALLY AND INHIBITED THEIR RANGE OF MOTION. IN ORDER TO HELP WITH THIS, THE SURGEON DECIDED TO REMOVE THE DISTAL FEMORAL COMPONENT IN ORDER TO EXTERNALLY ROTATE THE FEMUR AND HELP WITH THE LIMITED PATELLA FUNCTION AND OVERALL RANGE OF MOTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Fall; Joint Laxity; Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 17818620 ↗
• InjuryJan 18, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT COMES INTO EMERGENCY ROOM AND WITH PAIN AND NOT FEELING WELL. XRAYS SHOW HETEROTOPIC BONE FORMATION AND WHAT APPEARS TO BE GAS IN TISSUES SURROUNDING THE IMPLANT, SIGNIFYING INFECTION. ONCE OPENED, GROSS PUS WAS NOTED CONFIRMING INFECTION. A THOROUGH I&D WITH REMOVAL OF HETEROTOPIC BONE, EXCHANGE OF COMPONENTS, PLACEMENT OF ANTIBIOTIC BEADS AND COATING OF PROSTHESES WITH HIGH DOSE ANTIBIOTIC CEMENT IS PERFORMED. CEMENT WAS LIKELY GMV WITH GENT BUT WOULD HAVE BEEN HOSPITAL OWNED SO NO LOT INFO OR CONFIRMATION IS AVAILABLE IN MY RECORDS. NO PATIENT HARM OCCURRED. THIS PATIENT DOES HAVE MULTIPLE SIGNIFICANT COMORBIDITIES WHICH MAKE HER MORE PRONE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Extraskeletal ossification; Pain; Unspecified Infection

  MAUDE report 16195548 ↗
• InjuryFeb 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED FOR ASEPTIC LOOSENING. DOI: (B)(6) 2013; DOR: (B)(6) 2018; AFFECTED SIDE : UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Fall; Limb Fracture; Pain

  MAUDE report 13542825 ↗
• InjurySep 13, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION LPS DISTAL FEMUR - LOOSENING AT FEMORAL IMPLANT INTERFACE. CEMENTED STEM LPS INSITU - WIDE CANAL ON MALE PATIENT THOUGHT TO BE THE REASON FOR LOOSENING AT INTERFACE. DOI: UNKNOWN, DOR: UNKNOWN, UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 12460307 ↗