LCP 02.001.324SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982027702), received between Dec 12, 2018 and Dec 12, 2018 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K041911); they may or may not involve this specific model.

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

• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT A HARDWARE REMOVAL OF THE FEMUR WHICH INCLUDED ONE (1) LOCKING COMPRESSION PLATE, SIX (6) UNKNOWN LOCKING SCREWS, AND ELEVEN (11) UNKNOWN CORTEX SCREWS. PROCEDURE WAS DUE TO THE PATIENT EXPERIENCING KNEE STIFFNESS AND PAIN. PATIENT WAS ORIGINALLY SHOT IN THE KNEE, CAUSING EXTREMELY BAD FRACTURES ALONG WITH VASCULAR INJURY. THE FRACTURES ALL HEALED SUCCESSFULLY AND THE HARDWARE PERFORMED CORRECTLY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) LCP CONDYL-PL 4.5/5 CURV R 14HO L314 SST . THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 8157778 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041911. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2014 · Jul 30, 2013 · Terminated
  Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.