LPS 1987-16-212Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295078869), received between Dec 22, 2020 and Jun 1, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2021Inadequacy of Device Shape and/or Size; Osseointegration Problem; Inadequacy of Device Shape and/or Size; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM COMPONENT AT THE BONE TO IMPLANT INTERFACE. PATIENT HAD LPS IMPLANTED ON (B)(6) OF THIS YEAR. SOON AFTER SURGERY AND PATIENT WAS AT HOME THE IMPLANT "TWISTED." PATIENT HAD NO FALL OR TRAUMA. SURGEON BELIEVES IT WAS AN UNDERSIZED STEM BOTH IN LENGTH AND DIAMETER THAT WAS INITIALLY IMPLANTED CAUSING THE FAILURE. THE COMPONENTS WERE REMOVED AND REAMED A LARGER SIZE. TRIALED AND SEEMED STABLE GOING UP IN DIAMETER AND LENGTH. SURGEON WAS INFORMED THAT IT WAS OFF LABEL TO REUSE THE DISTAL FEMUR AND SEGMENT COMPONENT. IT WAS SURGEON DECISION TO REUSE ALL EXPLANTED PRODUCT AND ONLY REPLACE THE STEM WITH A NEW ONE. PRODUCTS THAT WERE RE-IMPLANTED: 1987-14-105, J99G01; 1987-07-035, J3517X; 1987-27-118, J70Z49. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 11913499 ↗
• InjuryDec 22, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DISTAL FEMORAL REPLACEMENT ON (B)(6) 2020. HE SUFFERED A FALL WITH SUBSIDENCE OF THE FEMUR AND LOOSENING OF THE POROUS STEM (NON-CEMENTED) AT THE BONE TO IMPLANT INTERFACE. THE PATIENT WAS BROUGHT TO SURGERY AND THE STEM WAS REPLACED WITH A LARGER STEM. ADDITIONAL SEGMENTAL PORTIONS WERE PLACED AND THE DISTAL FEMUR IMPLANT WAS REUSED. THEN, THE TIBIAL INSERT WAS PLACED. NO SURGICAL DELAY WAS NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 11056880 ↗