LPS 1987-15-211Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295078739), received between May 15, 2018 and Oct 24, 2025 — classified as 6 injuries.

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

• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PROGRESSIVE LUCENT LINES AROUND COMPONENTS AND PAIN, SUGGESTING FAILED FIXATION. IMPLANTS WERE REMOVED UNEVENTFULLY AND REIMPLANTED WITH NEW COMPONENTS. FROZEN SECTION WAS NEGATIVE FOR INFECTION. CEMENT HAD NOT ADHERED TO THE BONE, BUT THE TIBIAL SLEEVE WAS WELL FIXED AND THUS LEFT IN PLACE. THE FEMORAL COMPONENTS HAD BEEN REVISED ON (B)(6) 2024 FOR FAILED INGROWTH AND A CEMENTED STEM WAS PLACED AT THAT TIME. POLY WAS REVISED (B)(6) 2024 WHEN EXCESSIVE SCAR TISSUE WAS REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23380101 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DESPITE REPEATED ATTEMPTS TO CURE THE SYSTEMIC INFECTION THIS PATIENT HAD, PATIENT CONTINUED TO SHOW INFECTION AND IT WAS DECIDED TO REMOVE THE IMPLANTS IN HIS RIGHT LEG AND PERFORM AN ABOVE KNEE AMPUTATION. ALL COMPONENTS PERFORMED AS EXPECTED TO THERE WAS NO ALLEGATION AGAINST THE COMPONENTS. THIS SUBMISSION IS BEING MADE AS THE IMPLANTS WERE REMOVED. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 22688986 ↗
• InjurySep 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS BROUGHT TO OR TO ADDRESS CONTINUED DRAINAGE. SURGEON PLANNED TO EXCHANGE ALL MODULAR COMPONENTS HOWEVER WHEN THE FEMORAL STEM WAS CHECKED FOR FIXATION, SURGEON SAW SOME MOVEMENT AND THE STEM WAS ABLE REMOVED. THERE WAS AN AREA PROXIMALLY ON THE INCISION THAT SEEMED TO BE IRRITATED AND CULTURES WERE SENT FROM THIS AREA. FROZEN SECTION WERE ALSO SENT AT THE TIME OF THE SURGERY AND FROZEN SECTION DID SHOW 3 WHITE CELLS PER HIGH POWERED FIELD WHICH WAS INCONCLUSIVE. TIBIAL COMPONENTS APPEARED TO BE WELL FIXED. THERE WAS LOOSENING OF FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. A NEW STEM WAS CEMENTED INTO THE WELL FIXED CEMENT MANTLE IN THE FEMUR AND MODULAR COMPONENTS WERE REPLACED WITHOUT DELAY OR PATIENT HARM. THE STEM WAS PLACED ON (B))(6) 2024 AND THE OTHER COMPONENTS HAD BEEN PLACED ON THE DATE LISTED ABOVE. CEMENT WAS HOSPITAL OWNED SO NO LOT INFORMATION WAS AVAILABLE, CEMENT WAS DEPUY GMV. DOI: (B)(6), 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163145 ↗
• InjuryAug 16, 2023Fracture; Fracture

  THE PATIENT CONSULTS ON (B)(6) 2023 FOR PAIN AND AUDIBLE CRACK IN THE THIGH RIGHT WITH FUNCTIONAL IMPOTENCE. ON IMAGING, OBSERVATION OF THE FRACTURE OF THE STEM CENTRO MEDULLARY ABOUT 3 CMS FROM THE SECTION BONE, WITHOUT ASSOCIATED LOOSENING, WITHOUT TRAUMA. SURGICAL INTERVENTION ON (B)(6) 2023 FOR REPLACEMENT WITH A PROSTHESIS RECONSTRUCTION OF LPS DISTAL FEMUR WITH STEM DIAMETER 15MM, LENGTH 150MM. DOI: (B)(6) 2022. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture; Pain

  MAUDE report 17556590 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FEMORAL STEM PERFORATION.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10358129 ↗
• InjuryMay 15, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN. LOOSENING OF FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER USED WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7515490 ↗