LCP 241.918Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982167644), received between Feb 12, 2019 and Mar 17, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 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.

• InjuryMar 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE PROXIMAL HUMERUS WITH A REVERSE PELVIC SHOULDER DUE TO BACKING OUT AND LOOSENING OF THE SIX (6) UNKNOWN LOCKING SCREWS OF THE PROXIMAL HUMERUS PLATE. THE ORIGINAL DATE OF IMPLANT WAS ON FEBRUARY 14, 2020 AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THAT TIME. THIS REPORT IS FOR ONE 3.5MM LCP® PROXIMAL HUMERUS PLATE-LONG 5H SHAFT/142MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9841634 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS NOTED THREE LOCKING SCREWS WERE BROKEN, BUT IT WAS DIFFICULT TO DETERMINE IF THE SCREWS BROKE DURING REMOVAL OR IF THEY WERE ALREADY BROKEN. A PART OF THE BROKEN SCREW REMAINED IN THE SHAFT OF THE BONE. THIS REPORT IS FOR THE POST-OPERATIVE NON-UNION. THE BROKEN LOCKING SCREWS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

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

  MAUDE report 8333786 ↗