LCP 02.001.322SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982027689), received between May 7, 2024 and May 8, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RETROSPECTIVE POST MARKET STUDY (PMCF DATA) WAS RECEIVED, FOR THE TIMEFRAME OF NOVEMBER 2013 TO OCTOBER 2023, WHICH INCLUDES SAFETY RELATED DATA ON DISTAL FEMUR PLATES. THE PATIENT EXPERIENCED SEPTIC KNEE AND SURGICAL INTERVENTION AT 17 WEEKS. THIS COMPLAINT IS RELATED TO (B)(4), WHICH CAPTURES AN ADDITIONAL FOUR SCREWS RELATED TO THIS CASE. AT 38 WEEKS THE PATIENT EXPERIENCED DELAYED UNION AND NO EVIDENCE OF SURGICAL, WHICH IS CAPTURED IN (B)(4). THIS REPORT INVOLVES ONE (1) 4.5MM LCP® CURVED CONDYLAR PLATE 12H/278MM/RIGHT-STERILE. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19268001 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RETROSPECTIVE POST MARKET STUDY (PMCF DATA) WAS RECEIVED, FOR THE TIMEFRAME OF NOVEMBER 2013 TO OCTOBER 2023, WHICH INCLUDES SAFETY RELATED DATA ON DISTAL FEMUR PLATES. THE PATIENT EXPERIENCED ARTHROFIBROSIS KNEE WITH SURGICAL INTERVENTION. THIS COMPLAINT IS RELATED TO (B)(4), WHICH CAPTURES AN ADDITIONAL SCREW RELATED TO THIS CASE. THIS REPORT INVOLVES ONE (1) 4.5MM LCP® CURVED CONDYLAR PLATE 12H/278MM/RIGHT-STERILE. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 19261059 ↗

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.