VA-LCP 02.124.419Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982042996), received between Oct 24, 2017 and Mar 10, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2023Migration; Migration

  IT WAS REPORTED THAT THE SURGEON PERFORMED A REMOVAL OF A VA CONDYLAR PLATE DUE TO PROMINENT HARDWARE ON (B)(6) 2023. THE INITIAL SURGERY WAS DONE 18 MONTHS AGO. THE HARDWARE WAS SUCCESSFULLY REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16520492 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2021 THE PATIENT UNDERWENT REVISION DUE TO MALUNION OF DISTAL FEMUR. THERE WAS NO SURGICAL DELAY REPORTED. THERE WERE FRAGMENTS GENERATED AND IT IS UNKNOWN IF THEY REMOVE EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT THIS REPORT IS 4 OF 10 (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 11528562 ↗
• InjuryJul 22, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE CONDYLAR PLATE WAS BROKEN. THE ORIGINAL DATE OF IMPLANTATION WAS IN (B)(6) OF 2020. A NEW PLATE WAS IMPLANTED SUCCESSFULLY. THE BROKEN FRAGMENTS WERE REMOVED EASILY WITHOUT ANY MEDICAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 10). THIS REPORT IS FOR 1 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10308889 ↗
• InjuryDec 5, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO VARIABLE ANGLE (VA)-CONDYLAR PLATE BROKE AT CONDYLAR FLARE. SURGEON STATES NON-UNION WHEN REMOVING THE PLATE. MINIMAL CALCIFICATION POSTERIOR. TOTAL KNEE ARTHROPLASTY (TKA) WAS PERFORMED ON THE PATIENT AFTER VA-CONDYLAR PLATE WAS REMOVED. THE PATIENT ORIGINALLY IMPLANTED WITH VA-CONDYLAR PLATE AND UNKNOWN SCREWS ON (B)(6) 2019. THE PATIENT DID NOT REPORT AN INCIDENT THAT TRIGGERED BREAKAGE. THE PATIENT WAS NON-WEIGHT BEARING FOR 6 WEEKS FOLLOWING SURGERY. THE PLATE AND SCREWS WERE EXPLANTED. THE PROCEDURE AND PATIENT OUTCOMES ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9416273 ↗
• MalfunctionAug 9, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING DISTAL FEMUR PROCEDURE ON (B)(6) 2018, TWO (2) INTERLOCKING BOLTS, ONE (1) 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE AND ONE (1) LOCKING/NEUTRAL GUIDE FOR 4.5MM VA LCP CURVED CONDYLAR AIMING ARM WAS DAMAGED. WHILE ASSEMBLING VA-LCP CURVED CONDYLAR PLATE ON THE INSERTION HANDLE FOR PERCUTANEOUS AIMING ARM, THE VA-LCP LOCKING HOLE BECAME STRIPPED. AFTER INSPECTION, ANOTHER PLATE WAS ASSEMBLED AND IMPLANTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS NOT KNOWN IF THERE WAS A SURGICAL DELAY RELATED TO THE REPORTED EVENT. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: INSERTION HANDLE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.5MM VA LCP CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7767594 ↗
• InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO NON¿UNION AND INFECTION. ONE (1) VARIABLE ANGLE DISTAL PLATE, ELEVEN (11) VARIABLE ANGLE LOCKING SCREWS, TWO (2) 3.5 CORTEX SCREWS, ONE (1) LOCKING COMPRESSION PLATE PROXIMAL MEDIA TIBIA, ONE (1) T PLATE, SIX (6) LOCKING COMPRESSION PLATE SCREWS, AND FIVE (5) CORTEX SCREWS WERE REMOVED AND WERE REPLACED WITH A NEW VA DISTAL FEMUR PLATE AND A RETROGRADE/ANTEGRADE FEMORAL NAIL (RFNA). THE DATE OF THE ORIGINAL PROCEDURE IS UNKNOWN BUT WAS REPORTED MORE THAN SIX MONTHS BEFORE THE REPORTED ISSUES. IT WAS NOTED THE NON-UNION OCCURRED IN THE DISTAL FEMUR AND THE INFECTION DEVELOPED IN THE PROXIMAL TIBIA. ON AN UNKNOWN DATE, THE TIBIA WAS WASHED OUT AND DEBRIDED AND PLATES REMOVED. THE FEMUR WAS TO BE BONE GRAFTED; HOWEVER, IT WAS DISCOVERED A LARGE FRAGMENT OF BONE HAD DIED. THIS WAS REMOVED AND CEMENT SPACER WAS INSERTED. FEMORAL IMPLANTS REMAINED IN SITU. ON (B)(6) 2018, THE FEMORAL FIXATION WAS REVISED WITH VA DISTAL FEMUR PLATE AND RAFN NAIL AND BONE GRAFT. TIBIA IMPLANTS REMOVED, WASHED OUT AND SINUS EXCISED AS IT WAS STILL INFECTED. THERE WAS NO DELAY

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7650136 ↗
• InjuryApr 30, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT SECONDARY OPERATION. DURING THE PROCEDURE, WHILE TAKING THE ANTIBIOTIC BEAD OUT OF THE PATIENT, A 4.5 MM VA-LCP CONDYLAR PLATE SET WITH 18 HOLES ON THE LEFT SIDE WAS FOUND TO HAVE A SMALL BREAKAGE. ADDITIONAL OPERATIVE TIME, LENGTH UNKNOWN, WAS NEEDED IN THE ORTHOPEDIC PROCEDURE. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 4.5 CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY: UNKNOWN) 5.0 VA LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY: UNKNOWN) THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7473108 ↗
• InjuryOct 24, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF A VARIABLE ANGLE (VA) CONDYLAR PLATE ON (B)(6) 2017 DUE TO NONUNION AND A BROKEN PLATE. THE ORIGINAL SURGERY WAS CONDUCTED ABOUT SIX (6) WEEKS AGO AND THE CONSTRUCT INCLUDED A VA CONDYLAR PLATE, AN UNKNOWN CABLE TO HELP WITH THE PERIPROSTHETIC FEMUR FRACTURE REPAIR, TWO (2) 4.5 MM CORTICAL SCREWS, FIVE (5) VA CANNULATED LOCKING SCREWS AND FOUR (4) VA LOCKING SCREWS. ALL PARTS BUT THE PLATE WERE REMOVED INTACT. THE REMOVAL SURGERY WAS SUCCESSFUL AND UNEVENTFUL. THE PATIENT WAS REPORTED TO BE STABLE. IT IS UNKNOWN IF THE PATIENT WILL BE REVISED TO ANOTHER SET OF IMPLANTS. CONCOMITANT DEVICES REPORTED: CABLE (QUANTITY# 1). THE 4.5 MM CORTICAL SCREWS (QUANTITY# 2). VA CANNULATED LOCKING SCREWS (QUANTITY# 5). VA LOCKING SCREWS (QUANTITY# 4). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6973126 ↗

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