LCP 03.120.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982074027), received between Sep 6, 2019 and Jan 10, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A PROCEDURE THE SURGEON WAS USING A 4.5 PROXIMAL TIBIA AIMING ARMS. ONE OF THE GUIDE SLEEVES WOULD NOT PROPERLY SNAP INTO THE AIMING ARM. THE AIMING ARM ALSO DID NOT PERFECTLY ALIGN WITH THE PLATE. THE SURGEON RECOMMENDED REPLACING THE INSERTION HANDLE AND AIMING ARM BECAUSE HE FELT THEY WERE NOT FUNCTIONING PROPERLY. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITH NO DELAYS. THIS REPORT IS FOR ONE (1) AIM-ARM F/LCP PROX-TIB-PL4.5/5 LE THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18483616 ↗
• MalfunctionFeb 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE AIMING ARM SLEEVE MECHANISM FEATURE DOES NOT WORK PROPERLY. THE RECESS (MECHANISM TO ATTACH THE SLEEVE) ARE USED AND DOESN'T WORK PROPERLY THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) PERIARTIC AIM ARM 4.5 LCP PROX TIB PL-LT. THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329339 ↗
• MalfunctionSep 6, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE ON AN UNKNOWN DATE TO TREAT A TIBIA FRACTURE, WHILE INSERTING AN UNKNOWN SCREWS THROUGH THE LOCKING COMPRESSION PLATE (LCP) TIBIA LEFT AIMING ARM, THE SCREWS WERE MISSING THE LCP TIBIAL PROXIMAL PLATE UPON INSERTION WITH A GUIDE SLEEVE WHEREIN THE GUIDE SLEEVE WAS FINE. IT WAS NOTICED THAT THE REPORTED AIMING ARM HAS TOO MUCH QUAINT IN IT DUE TO 20 YEARS OF USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TEN (10) MINUTES OF SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: LCP TIBIAL PROXIMAL PLATE (PART # 240.045, LOT # UNKNOWN, QUANTITY 1), GUIDE SLEEVE (PART # 03.120.014, LOT # UNKNOWN, QUANTITY 2), UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Patient Involvement

  MAUDE report 8971070 ↗