LCP 222.663Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982157423), received between Feb 26, 2018 and Apr 22, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION ON (B)(6) 2019 DUE TO A BROKEN CONDYLAR PLATE AND NON-UNION. FRACTURES WERE TREATED WITH NEW PLATES AND SCREWS. THE PATIENT HAD AN ORIGINAL IMPLANT OF ONE (1) CONDYLAR PLATE, ONE (1) UNKNOWN 7.3MM CANNULATED LOCKING SCREW, FOUR (4) 5.0MM CANNULATED LOCKING SCREW AND FOUR (4) 4.5MM CORTEX SCREW ON (B)(6) 2018. THE ONLY BROKEN DEVICE WAS THE DISTAL FEMUR PLATE AT HOLE #1 ON THE SHAFT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: 6.5/7.3 MM CANNULATED (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNK - SCREWS: 5.0 MM CANNULATED (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 4). UNK - SCREWS: CORTEX: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 4). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8538061 ↗
• InjuryFeb 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT WILL HAVE TO UNDERGO A REVISION SURGERY ON (B)(6) 2018 FOR REMOVAL OF BROKEN 4.5 MM LOCKING COMPRESSION (LCP) CONDYLAR PLATE 12 HOLES/278 MM-LEFT AND TREATMENT OF DISTAL FEMORAL NON-UNION. THE PATIENT WAS IMPLANTED WITH A 4.5 MM LCP CONDYLAR PLATE AND A COMBINATION OF CORTEX AND LOCKING SCREWS FOR A DISTAL FEMUR FRACTURE ON AN UNKNOWN DATE. FURTHER IT WAS REPORTED THAT THE PATIENT DIDN'T SHOWED UP FOR THE REVISION SURGERY SCHEDULED FOR (B)(6) 2018. IT IS UNKNOWN AS OF RIGHT NOW THAT WHETHER AND WHEN THE REVISION SURGERY WILL TAKE PLACE IN THE FUTURE. CONCOMITANT DEVICES REPORTED: CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QTY # UNKNOWN), LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QTY # UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 7296377 ↗