LCP 222.658Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982157324), received between Aug 21, 2017 and Aug 29, 2018 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF THE LOCKING COMPRESSION CONDYLAR PLATE, CANNULATED LOCKING SCREWS AND CORTEX SCREWS DUE TO NON-UNION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ALL HARDWARE WAS SUCCESSFULLY REMOVED WITH NO ISSUE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 7829678 ↗
• InjuryAug 21, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017 OF A 4.5 MM LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE AND TEN (10) SCREWS OF THE DISTAL FEMUR. THE PATIENT WAS REVISED AS THE PLATE BROKE POSTOPERATIVELY DUE TO NONUNION. THE PLATE AND SCREWS WERE ORIGINALLY IMPLANTED IN (B)(6) 2016; AND WERE REPLACED WITH A NEW PLATE AND SCREWS (UNKNOWN QUANTITY) ON (B)(6) 2017. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY AND GOOD PATIENT OUTCOME. CONCOMITANT DEVICES REPORTED: SCREWS (QUANTITY 10). THIS REPORT IS FOR ONE (1) 4.5 MM LCP CONDYLAR PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6807911 ↗