LCP 222.659Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982157348), received between Jun 12, 2018 and Jun 12, 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 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 DUE TO NONUNION OF THE LEFT DISTAL FEMUR. THE SURGEON REMOVED ONE (1) LOCKING COMPRESSION PLATE (LCP) CONDYLAR 8-HOLE PLATE, FOUR (4) 4.5MM CORTEX SCREWS, ONE (1) 7.3MM LOCKING SCREW, AND FOUR (4) 5.0MM LOCKING SCREWS. THE NONUNION WAS IRRIGATED, DEBRIDED, AND SEPARATED. BONE SAMPLES WERE SENT OUT FOR INFECTION TESTING. REAMER/IRRIGATOR/ASPIRATOR (RIA) WAS USED FOR BONE GRAFT HARVEST IN IPSILATERAL FEMUR. THE PROCEDURE WAS REVISED WITH A NON-SYNTHES RETROGRADE FEMORAL NAIL. IT WAS REPORTED THAT THE REASON FOR NON-UNION WAS SUSPECTED TO BE THE RIGID CONSTRUCT OF THE LOCKING SCREWS TOO CLOSE TO THE FRACTURE. ALL THE PREVIOUS IMPLANTS WERE REMOVED AND ARE INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED DELAY. CURRENT PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR 4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-LEFT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 7591274 ↗