LCP 224.611Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982158567), received between Dec 24, 2019 and Dec 24, 2019 — classified as 1 injury.

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. 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 24, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A BROKEN NARROW LOCKING COMPRESSION PLATE (LCP) PLATE AND NON-UNION OF THE TIBIA WITH DELAYED HEALING. THE PATIENT HAD HER FIRST TOTAL KNEE SURGERY IN 2014 WHICH WAS REVISED IN 2015. ON (B)(6) 2017 HER TOTAL KNEE WAS EXPLANTED AND AN ANTIBIOTIC SPACER WAS PLACED. ON (B)(6) 2019, THE PATIENT HAD A NEW TOTAL KNEE PLACED AND WAS REINFORCED WITH A SYNTHES PLATE. THE SYNTHES PLATE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION AND A LONGER STEM WAS USED ON THE BIOMET PROSTHESIS. THERE WAS NO REPORTED SURGICAL DELAY. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 4), UNKNOWN CABLES (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 4). THIS REPORT IS FOR ONE 4.5MM NARROW LCP® PLATE 11 HOLES/ 206MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 9516557 ↗