LCP 242.124Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982168146), received between Mar 25, 2020 and Mar 25, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryMar 25, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS TREATED FOR A BROKEN FEMUR WITH IM NAILS TWICE AND THE NAILS BROKE BOTH TIMES. THE PATIENT WAS TREATED ON (B)(6) 2020 WITH A FIBULA ALLOGRAFT DOWN THE CANAL OF THE FEMUR AND THE PROXIMAL FEMUR HOOK PLATE. THE FEMUR HAD LOST LENGTH, SO WHEN REGAINING LENGTH THERE WAS A GAP AT THE FRACTURE SITE WHERE THE FIBULA ALLOGRAFT AND PLATE WOULD BE SHARING LOAD. AT SOME POINT AFTER THE PATIENT BEGAN WEIGHT-BEARING, THE FIBULA ALLOGRAFT FAILED CAUSING THE PLATE TO BEAR THE LOAD, WHICH LEAD TO A FATIGUE FAILURE OF THE PLATE. ON (B)(6) 2020 THE PATIENT UNDERWENT SURGERY TO HAVE THE BROKEN PLATE REMOVED AND THE FIXATION REVISED. THE SURGEON REPLACED THE BROKEN PLATE AND ADDED A FEMORAL SHAFT ALLOGRAFT ON THE MEDIAL SIDE OF THE PATIENT'S FEMUR. SCREWS WERE PLACED THROUGH THE PLATE ACROSS THE FEMUR AND THROUGH THE ALLOGRAFT SPLINT TO PROVIDE LOAD-SHARING AND STABILITY ON BOTH SIDE OF THE FRACTURE. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 9). THIS REPORT IS FOR ONE (1) 4.5MM LCP PROXIMAL FEMUR HOOK PL

  Patient problems: No Code Available

  MAUDE report 9879024 ↗