LCP 02.001.322Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982027672), received between Nov 16, 2017 and Mar 21, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY AND HARDWARE REMOVAL ON (B)(6) 2025. ON (B)(6) 2024, A 4.5MM LCP CURVED CONDYLAR PLATE WAS PLACED IN ORDER TO TREAT A DISTAL FEMUR FRACTURE WITH INTRAARTICULAR EXTENSION. THE PLATE REACHED A POINT OF MECHANICAL FAILURE APPROXIMATELY ON (B)(6) 2025, LEADING TO NONUNION. THE BROKEN PLATE AND INTACT SCREWS WERE REMOVED FROM THE PATIENT AND A RETROGRADE FEMORAL NAIL WAS INSERTED DURING THE REVISION PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE, NO SURGICAL DELAY.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21667612 ↗
• InjuryMar 29, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF OPEN REDUCTION AND INTERNAL FIXATION (ORIF) IN RIGHT FEMUR DUE TO NON-UNION. THE LOCKING COMPRESSION PLATES (LCP) CURVED CONDYLAR PLATE 12 HOLES HAD BROKEN AND SEVERAL OF THE SCREWS HAD LOOSENED. ALL HARDWARE WERE REMOVED COMPLETELY INCLUDING 1 PLATE, 3 CABLES, AND 9 SCREWS WITH NO DIFFICULTIES. THE RIGHT FEMUR REVISION PLATING WAS PERFORMED ALONG WITH BONE GRAFTING. THERE WAS UNKNOWN SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN CABLES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 3).   THIS COMPLAINT INVOLVES TWO (2) DEVICES.  THIS REPORT IS FOR ONE (1) 4.5MM LCP® CURVED CONDYLAR PLATE 12 HOLES/278MM-RIGHT. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8467014 ↗
• InjuryJan 19, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE A PATIENT RECEIVED A 4.5MM LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE ON AN UNKNOWN DATE. PATIENT EXPERIENCED PERIPROSTHETIC MID SHAFT FEMUR FRACTURE BETWEEN A PROSTHETIC HIP AND KNEE DUE TO THE PLATE BREAKING APPROXIMATELY NINE (9) MONTHS POST-OPERATIVELY. THE PATIENT WAS NOT REVISED. SURGEON FEELS STRONGLY THAT THIS IS ALL RELATED TO PATIENT¿S AGE (BIOLOGICALLY UNABLE TO HEAL PROPERLY). THIS REPORT IS FOR ONE (1) 4.5MM LCP® CURVED CONDYLAR PLATE 12 HOLES/278MM-RIGHT. (B)(4).

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

  MAUDE report 7207151 ↗
• InjuryNov 16, 2017Break; Break

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 4.5MM LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE 12 HOLES 278MM RIGHT, NINE (9) LOCKING SCREWS, AND ONE (1) CORTEX SCREW FOR A FEMUR FRACTURE. POST-OPERATIVELY, IT WAS DISCOVERED THAT THE PLATE BROKE AT THE SITE OF THE ORIGINAL FRACTURE. REVISION SURGERY TOOK PLACE ON (B)(6) 2017, WHERE THE SURGEON REMOVED ONE (1) BROKEN PLATE AND TEN (10) INTACT SCREWS. PATIENT WAS REVISED WITH A NEW PLATE AND AN UNKNOWN QUANTITY OF SCREWS. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS REPORTED AS STABLE. PATIENT HISTORY INCLUDES CHRONIC NARCOTIC USE. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 9), CORTEX SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM LCP CURVED CONDYLAR PLATE 12 HOLES 278MM RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7036975 ↗

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.