VA-LCP 02.124.418Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982042972), received between Apr 25, 2018 and Feb 2, 2023 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRA-OP WHILE ATTACHING THE PERCUTANEOUS AIMING ARM ON THE VA-LCP CURVED CONDYLAR PLATING SYSTEM, THE VA HOLE THAT ATTACHES TO THE AIMING ARM STRIPPED. THE PLATE WAS UNABLE TO BE USED. A PLATE ONE SIZE IN LENGTH WAS USED AND ABLE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, OR ANY FRAGMENTS WERE GENERATED OR IF THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284966 ↗
• InjuryAug 4, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS 4.5 VA-LCP CURVED CONDYLAR PLATE FAILURE- PLATE BROKE. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15164226 ↗
• MalfunctionOct 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE FOR A DISTAL FEMUR FRACTURE, THE SURGEON WAS COMPLAINING ABOUT THE PLATE FIT AND HOW FAR THE PLATE ON THE PLATE WAS SETTING OFF THE BONE. SHE ACCEPTED THE PLATE SETTING OFF THE BONE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707927 ↗
• InjurySep 22, 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 FOR A REVISION SURGERY. DURING THE SURGERY, THE HARDWARE WAS REMOVED FROM THE PATIENT'S FEMUR AND USED RIA TO GET BONE GRAFT FROM OPERATIVE FEMUR DUE TO A NONUNION FROM THE PREVIOUS SURGERY. SURGEON REVISED FEMUR USING A UNIVERSAL FEMORAL NAIL, AND A VA CONDYLAR PLATE. HE THEN PUT IN BONE GRAFT COLLECTED FROM RIA IN THE NONUNION SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S SURGERY WAS REVISED. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR (1) 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT. THIS REPORT IS 1 OF 14 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12514192 ↗
• InjuryMay 24, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, VARIABLE ANGLE CONDYLAR PLATE AND ONE CABLE BROKE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11872484 ↗
• InjuryMay 12, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED, BY A DISAPPOINTED AND FRUSTRATED SURGEON THAT THREE OF HIS PATIENTS, PLUS TWO PATIENTS OF HIS COLLEAGUE SURGEON (FOR A TOTAL OF FIVE PATIENTS) WHO HAVE EXPERIENCED A 4.5MM VARIABLE ANGLE LCP (VA-LCP) CURVED CONDYLAR BRIDGE PLATE CONSTRUCT FAILURE AFTER VERY SHORT TIME AND HAD TO GO FOR A POST-OP SURGERY IN THE MANAGEMENT OF HIGHLY COMMINUTED DISTAL FEMORAL FRACTURE. I WAS ONLY TOLD OF THESE FIVE FRACTURES TODAY BUT THESE CONSTRUCT FAILURES HAVE HAPPENED IN LAST FEW MONTHS. SURGEON HAS PROMISED TO SUPPLY MORE INFORMATION SHORTLY AND SUSPECT THAT THE COMBI HOLE FOUR COLUMN THREADS MAYBE THE SOURCE OF A STRESS RISER, AT SCREW/PLATE JUNCTION FAILURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11814509 ↗
• InjuryMay 12, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED, BY A DISAPPOINTED AND FRUSTRATED SURGEON THAT THREE OF HIS PATIENTS, PLUS TWO PATIENTS OF HIS COLLEAGUE SURGEON (FOR A TOTAL OF FIVE PATIENTS) WHO HAVE EXPERIENCED A 4.5MM VARIABLE ANGLE LCP (VA-LCP) CURVED CONDYLAR BRIDGE PLATE CONSTRUCT FAILURE AFTER VERY SHORT TIME AND HAD TO GO FOR A POST-OP SURGERY IN THE MANAGEMENT OF HIGHLY COMMINUTED DISTAL FEMORAL FRACTURE. I WAS ONLY TOLD OF THESE FIVE FRACTURES TODAY BUT THESE CONSTRUCT FAILURES HAVE HAPPENED IN LAST FEW MONTHS. SURGEON HAS PROMISED TO SUPPLY MORE INFORMATION SHORTLY AND SUSPECT THAT THE COMBI HOLE FOUR COLUMN THREADS MAYBE THE SOURCE OF A STRESS RISER, AT SCREW/PLATE JUNCTION FAILURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11813217 ↗
• InjuryMay 11, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) UNKNOWN SCREW AND ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE BROKE IN THE PATIENT. THE PATIENT EXPERIENCED NON-UNION AND REQUIRED REVISION SURGERY. THE ORIGINAL DATE OF SURGERY IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11807084 ↗
• InjuryJul 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PATIENT UNDERWENT THE REMOVAL OF OSTEOSYNTHESIS MATERIAL AND A CONDYLAR SUPPORT PLATE THAT HAD FAILED. THE DISTAL LOCKING SCREWS OF THE PLATE WERE LOOSE AND ONE WAS ALREADY EXPOSED OUTSIDE OF THE SKIN. AN ADDITIONAL REDUCTION WAS PERFORMED BUT THE SCREWS DID NOT BLOCK THE PLATE AND IT WAS DECIDED TO REMOVE ALL THE MATERIAL AND PUT A SPLINT IN ONE OF THE WOUNDS THAT WAS FOUND TO BE INFECTED. THE FIRST INTERVENTION WAS PERFORMED BECAUSE THE DISTAL SCREWS OF THE PLATE CAME OFF. THE SECOND OPERATION WAS PERFORMED TO EXTRACT A SCREW THAT WAS EXPOSED THROUGH THE SKIN AND THE THIRD INTERVENTION WAS WHEN ALL OF THE MATERIAL WAS REMOVED. THE FIRST TWO INTERVENTIONS WERE PERFORMED TO REMOVE THE IMPLANT AND TRY TO CORRECT THE NEW FRACTURE, IN THE LAST SURGERY IT WAS SHOWN THAT THERE WAS AN INFECTION. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT. THIS IS REPORT 1 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10313950 ↗
• InjuryDec 11, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 4.5 MM VARIABLE ANGLE (VA) CURVED CONDYLAR PLATE BROKE POST-OPERATIVELY IN A PATIENT. IT IS UNKNOWN IF THE BROKEN DEVICE WAS REMOVED OR REVISED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.5 MM VA-LCP CURVED CONDYLAR PLATE/ 18 HOLE/ 370 MM/ RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9453161 ↗
• InjuryJul 23, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF A VARIABLE ANGLE (VA) PLATE, ELEVEN (11) VA LOCKING SCREWS, FOUR (4) CORTEX SCREWS, AND ONE (1) 6.5 OR 7.3MM CANNULATED SCREW. IT IS NOT KNOWN WHEN THE VARIABLE ANGLE (VA) DISTAL FEMUR PLATE WAS IMPLANTED. THE PATIENT APPARENTLY STEPPED OFF A CURB AND THE PLATE BROKE AT THE SIXTH MOST DISTAL COMBI-HOLE DUE TO NON-UNION. NON-UNION OF THE MID-SHAFT AND DISTAL FEMUR WAS CONFIRMED BY THE SURGEON AFTER THE ENTIRE IMPLANT SYSTEM WAS REMOVED. SURGEON REPORTED TO THE SALES CONSULTANT THAT IT WAS A NON-UNION RATHER THAN THE PLATE'S FAULT. THE PATIENT IS SCHEDULED FOR REVISION TO A RETROGRADE NAIL AND DISTAL FEMUR PLATE ON (B)(6) 2018. EXPLANTATION SURGERY WAS SUCCESSFUL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO PATIENT OUTCOME WAS REPORTED. CONCOMITANT DEVICES: VA LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 11); CORTEX SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 4); CANNULATED SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 7710128 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF INTACT HARDWARE FROM THE FEMUR ON (B)(6) 2018 DUE TO AN INFECTION. THE BIPOLAR HIP (NON-SYNTHES), ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE, THREE (3) 5MM PERIPROSTHETIC LOCKING SCREWS, ONE (1) 5MM LOCKING SCREW, THREE (3) 4.5MM CORTEX SCREWS, AND SIX (6) 5MM CANNULATED LOCKING SCREWS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE PATIENT UNDERWENT AN INCISION AND DRAINAGE (I&D) PROCEDURE AND AN ANTIBIOTIC CEMENT SPACER WAS INSERTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS OK. CONCOMITANT DEVICES REPORTED: BIPOLAR HIP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN) THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7459079 ↗

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