LPS 1987-26-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295079279), received between May 20, 2019 and Oct 21, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT HAD HER KNEE REVISED ON (B)(6) 2022. SINCE THE SURGERY, THE LPS POROUS COATED STEM THE WAS IMPLANTED BECAME LOOSE. THE LPS DISTAL FEMORAL COMPONENT, POROUS COATED STEM, 85MM SEGMENT, AND 12MM LPS POLY WERE EXPLANTED AND REPLACED WITH A CEMENTED STEM CONSTRUCT. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15649595 ↗
• InjuryMar 9, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. PATIENT IS HAVING TISSUE BREAKDOWN FROM CHEMO TREATMENTS. REMOVED COMPONENTS AND WASHED OUT AND REVISED. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 13710180 ↗
• InjuryJul 15, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT SUFFERED A FALL AT HOME WHILST RECOVERING FROM HER SURGERY PERFORMED ON (B)(6) 2019 RESULTING IN THE LOOSENING OF THE LPS POROUS STEM. IF OTHER, DESCRIBE LPS DISTAL FEMORAL REPLACEMENT. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? YES. IF YES, PLEASE DESCRIBE. THE POROUS FEMUR LOOSENED AND ROTATED WITHIN THE CANAL FOLLOWING A FALL. DID PATIENT REQUIRE REVISION SURGERY? TRUE. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8790445 ↗
• InjuryMay 20, 2019Loss of Osseointegration; Malposition of Device; Migration; Loss of Osseointegration; Malposition of Device; Migration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE ENTIRE IMPLANT ROTATED.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8625148 ↗