LCP 02.001.306Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982027597), received between Jan 2, 2018 and Sep 23, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K041911); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF LOCKING COMPRESSION PLATE (LCP) CONDYLAR IMPLANTS DUE TO SYNDESMOSIS MAL-REDUCTION AND MALUNION OF DISTAL FEMUR FRACTURE. THE SURGEON REMOVED ONE (1) LCP CURVED CONDYLAR PLATE, FIVE (5) UNKNOWN 5.0MM LOCKING SCREWS, TWO (2) UNKNOWN 4.5MM CORTEX SCREWS, AND ONE (1) UNKNOWN 5.0MM CANNULATED SCREW. THE SURGEON REVISED MAL-UNION WITH ZIMMER RETROGRADE FEMORAL NAIL. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS AFTER THE REMOVAL PROCEDURE IS UNKNOWN. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) LCP CURVED CONDYLAR PLATE. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 9107154 ↗
• InjuryMar 6, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A DISTAL FEMUR FRACTURE OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE AND WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE. THE LCP CONDYLAR PLATE DEVELOPED A NON-UNION FRACTURE AND EVENTUALLY BROKE. IT IS UNKNOWN IF THERE WAS A REVISION SURGERY. THIS REPORT IS FOR ONE (1) 4.5MM LCP® CURVED CONDYLAR PLATE 16 HOLES/350MM-LEFT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 8395138 ↗
• InjuryJan 2, 2018Break; Break

  IT WAS REPORTED THAT AN UNKNOWN PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE WHERE A PATIENT WAS IMPLANTED WITH ONE (1) 4.5 CONDYLAR PLATE, TWO (2) 4.5 CORTEX SCREWS, SIX (6) LOCKING SCREWS AND TWO (2) 1.7 CABLES. POST-OPERATIVELY, THE PATIENT FELL AND IT WAS DISCOVERED VIA X-RAY ON AN UNKNOWN DATE THAT THE 4.5 CONDYLAR PLATE BROKE. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 WHERE ALL IMPLANTS WERE REMOVED AND PATIENT WAS IMPLANTED WITH NEW HARDWARE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND PATIENT STATUS WAS REPORTED AS STABLE. X-RAYS ARE NOT AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN 4.5 CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2), UNKNOWN 5.0 LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 6), UNKNOWN 1.7 CABLES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). THIS REPORT ADDRESSES THE REVISION SURGERY DUE TO POSTOPERATIVE BROKEN PLATE. THE INTRAOPERATIVE ISSUE OF SCREW BREAKAGE DURING REVISION SURGERY HAS BEEN CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM LCP CURVED CONDYLAR PLATE 16 HOLES/350MM-LEFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Fall

  MAUDE report 7158680 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041911. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2014 · Jul 30, 2013 · Terminated
  Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.