VA-LCP 02.124.414SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982042903), received between Sep 27, 2018 and May 3, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K083025, K110354); 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 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON APRIL 4, 2022, A HARDWARE REMOVAL OF A RETROGRADE FEMORAL NAIL -ADVANCED SYSTEM (RFNA) NAIL CONSTRUCT AND A VARIABLE ANGLE (VA) CONDYLAR PLATE CONSTRUCT WERE REMOVED FROM A FEMUR BECAUSE OF INFECTION. THE DEVICES WERE ORIGINALLY IMPLANTED ON FEBRUARY 16, 2022 AND EXPLANTED ON APRIL 4, 2022. NO ALLEGATIONS WERE MADE ON THE DEVICES FROM THE SURGEON. THE SURGEON REMOVED THE PROXIMAL SCREWS, AND PERFORMED AN AMPUTATION TO REMOVE REMAINING HARDWARE ON ONE PIECE. THE EXACT TOTAL NUMBER OF IMPLANTED SCREWS REMOVED IS UNKNOWN. THE PROCEDURE OUTCOME WAS UNKNOWN. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR A VA CONDYLAR PLATE.

  Patient problems: Unspecified Infection

  MAUDE report 14270405 ↗
• InjurySep 27, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A HARDWARE REMOVAL OF A BROKEN VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CONDYLAR PLATE AND TEN (10) SCREWS. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. PATIENT WAS REVISED TO A RETROGRADE FEMORAL ROD. THE PATIENT¿S LIMB WAS ENTIRELY REDUCED FROM THE INITIAL SURGERY AND ALLOWED FOR AN INTRAMEDULLARY NAIL (IM). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS STABLE. THE SURGEON NOTED THAT THE PATIENT WAS UNDERGOING RADIATION TREATMENT FOR CANCER PRIOR TO AND AFTER THE INITIAL SURGERY ON (B)(6) 2018. HE BELIEVES THAT THIS TREATMENT NEGATIVELY AFFECTED THE PATIENT¿S ABILITY TO CREATE NEW BONE AND HEAL THE FRACTURE. AFTER MONTHS OF LOAD BEARING BY THE PLATE, AS OPPOSED TO LOAD SHARING WHICH TYPICALLY HAPPENS WHEN A BONE BEGINS TO HEAL, THE PLATE SNAPPED. CONCOMITANT DEVICES: TRAUMA SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 10). THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE/14-HOLE/301MM/RIGHT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7915522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083025, K110354. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2014 · Feb 5, 2014 · Terminated
  Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
• Z-0401-2014 · May 29, 2013 · Terminated
  Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra