LCP 222.660Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982157362), received between Mar 26, 2018 and Feb 11, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO BROKEN 4.5 LCP CONDYLAR PLATE, BROKEN 5.0 CANNULATED LOCKING SCREW, BROKEN 4.5 SCREW, AND NONUNION FEMUR. ALL HARDWARE WAS REMOVED. DATE OF IMPLANT IS UNKNOWN. CONCOMITANT DEVICES REPORTED: SCREWS: 5.0 MM CANNULATED (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 5), SCREWS: 6.5 MM AND 7.3 MM CANNULATED (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), SCREWS: CORTEX (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS REPORT INVOLVES ONE (1) 4.5MM LCP® CONDYLAR PLATE 10 HOLES/242MM-RIGHT. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11315775 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE TO REMOVE THE 4.5 MM LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE AND UNKNOWN SCREWS FROM THE PATIENT¿S DISTAL FEMUR DUE TO NON-UNION. THE PATIENT WAS REVISED TO A PROSTHETIC DISTAL FEMUR. THE LCP AND SCREWS WERE INITIALLY IMPLANTED ON (B)(6) 2017 IN A FIRST REVISION SURGERY DUE TO THE PREVIOUS HARDWARE FAILING. THE FAILED HARDWARE FROM THAT SURGERY WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR A 4.5 MM LCP® CONDYLAR PLATE 10 HOLES/242 MM-RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT WILL ADDRESS THE LCP CONDYLAR PLATE AND UNKNOWN SCREWS REMOVED ON (B)(6) 2018. THE REVISION SURGERY ON (B)(6) 2017 HAS BEEN CAPTURED UNDER (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7793178 ↗
• InjuryMar 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A SYNTHES LOCKING COMPRESSION PLATE (LCP) DISTAL FEMUR PLATE AND 10 UNKNOWN SCREWS ON AN UNKNOWN DATE IN (B)(6) 2017 TO TREAT A DISTAL FEMUR FRACTURE. POSTOPERATIVELY, ON AN UNKNOWN DATE IN (B)(6) 2018, THE PATIENT PRESENTED WITH LEG PAIN AND WAS REFERRED TO THE EMERGENCY ROOM. ON AN UNKNOWN DATE, WHILE IN THE ER, IT WAS IDENTIFIED THAT THE PLATE HAD BROKEN AT ONE OF THE SCREW HOLES. ON (B)(6) 2018, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE SURGEON SUCCESSFULLY REMOVED THE 10 SCREWS AND THE BROKEN PLATE AND THE PATIENT WAS REVISED TO A 12-HOLE 4.5MM LCP BROAD PLATE, AN UNKNOWN QUANTITY OF UNKNOWN SCREWS, AND A NON-SYNTHES FIBULAR STRUT AND CABLES TO STABILIZE THE NON-UNION. THERE WERE NO INTRAOPERATIVE MALFUNCTIONS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 10). THIS REPORT IS FOR ONE (1) 4.5MM LCP CONDYLAR PLATE 10 HOLE 242MM RIGHT THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7371545 ↗