LCP 239.991Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982163974), received between Jun 29, 2018 and Jun 29, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO NON¿UNION AND INFECTION. ONE (1) VARIABLE ANGLE DISTAL PLATE, ELEVEN (11) VARIABLE ANGLE LOCKING SCREWS, TWO (2) 3.5 CORTEX SCREWS, ONE (1) LOCKING COMPRESSION PLATE PROXIMAL MEDIA TIBIA, ONE (1) T PLATE, SIX (6) LOCKING COMPRESSION PLATE SCREWS, AND FIVE (5) CORTEX SCREWS WERE REMOVED AND WERE REPLACED WITH A NEW VA DISTAL FEMUR PLATE AND A RETROGRADE/ANTEGRADE FEMORAL NAIL (RFNA). THE DATE OF THE ORIGINAL PROCEDURE IS UNKNOWN BUT WAS REPORTED MORE THAN SIX MONTHS BEFORE THE REPORTED ISSUES. IT WAS NOTED THE NON-UNION OCCURRED IN THE DISTAL FEMUR AND THE INFECTION DEVELOPED IN THE PROXIMAL TIBIA. ON AN UNKNOWN DATE, THE TIBIA WAS WASHED OUT AND DEBRIDED AND PLATES REMOVED. THE FEMUR WAS TO BE BONE GRAFTED; HOWEVER, IT WAS DISCOVERED A LARGE FRAGMENT OF BONE HAD DIED. THIS WAS REMOVED AND CEMENT SPACER WAS INSERTED. FEMORAL IMPLANTS REMAINED IN SITU. ON (B)(6) 2018, THE FEMORAL FIXATION WAS REVISED WITH VA DISTAL FEMUR PLATE AND RAFN NAIL AND BONE GRAFT. TIBIA IMPLANTS REMOVED, WASHED OUT AND SINUS EXCISED AS IT WAS STILL INFECTED. THERE WAS NO DELAY

  Patient problems: Unspecified Infection

  MAUDE report 7650986 ↗