DHHS 282.610Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982178664), received between May 8, 2020 and May 8, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO NON-UNION AND REVISION TO TOTAL HIP REPLACEMENT. THE ORIGINAL DATE OF IMPLANT WAS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED HELIX BLADE 95MM (PART NUMBER 282.238, LOT NUMBER H793959 , QUANTITIES 1), SCREWS: CANNULATED (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITIES 1). THIS COMPLAINT IS FOR ONE (1) 135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 2 HOLES. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 10039301 ↗