VA-LCP 02.124.414Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982042897), received between Mar 21, 2017 and Feb 23, 2022 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DURING A FEMUR ORIF WITH THE VA CONDYLAR SYSTEM, THE SURGEON WAS ATTEMPTING TO ASSEMBLE THE PERCUTANEOUS AIMING ARM TO THE 14-HOLE RIGHT PLATE AND FOUND THAT THE CONNECTION WAS NOT SECURE. THE LOCKING BOLT FOR THE AIMING ARM WOULD SCREW INTO THE CONNECTING LOCKING HOLE OF THE PLATE BUT WOULD PULL OUT ONCE THE LOCKING NUT WAS ASSEMBLED. IN ORDER TO DETERMINE WHETHER THE INSTRUMENT OR THE PLATE HOLE WAS FAULTY, THE SURGEON ATTEMPTED TO ASSEMBLE THE AIMING ARM TO THE 16-HOLE AND FOUND THAT IT CONNECTED TIGHTLY AND SECURELY. THEREFORE, IT WAS DETERMINED THAT THE THREADED LOCKING HOLE OF THE 14-HOLE PLATE MUST HAVE BEEN DAMAGED OR FAULTY. THERE WAS A 2-MINUTE DELAY AS A RESULT, BUT NO PATIENT CONSEQUENCE. THE 16-HOLE PLATE WAS USED INSTEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PHOTO AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE 4.5 VA-LCP CURVED COND PL/14 HOLE/301/RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584030 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A REVISION DUE TO FEMORAL NONUNION. THE SURGEON REMOVED A 4.5MM VARIABLE ANGLE CONDYLAR PLATE, AND SCREWS. THE SURGEON THEN USED AN RIA TO COLLECT BONE GRAFT AND INSERTED A RETROGRADE FEMORAL NAIL ADVANCED INTO THE FEMUR AND THEN PLACED A BONE GRAFT INTO THE NONUNION SITE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CURVED COND PL/14 HOLE/301/RT. THIS IS REPORT 1 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12464566 ↗
• MalfunctionAug 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A DISTAL FEMUR FRACTURE THE 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE CONDYLAR SYSTEM WAS USED. DURING THE OPERATION THE CONNECTING BOLT FOR THE PERCUTANEOUS OUTRIGGER FAILED TO ATTACH TO THE 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT. THERE WERE NO ISSUES WITH ATTACHMENT TO ANY OTHER LENGTH PLATE IN THE SYSTEM AND A SECOND INSTRUMENT SET OPENED DURING THE CASE PRODUCED THE SAME RESULT. THE 14 HOLE PLATE WAS USED WITHOUT THE OUTRIGGER, CAUSING MINIMAL DELAY, BUT GREATLY INCREASING SURGICAL DIFFICULTY. ADDITIONALLY, THE HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES WOULD PROPERLY ATTACH TO THE DRILL GUIDES. THIS WAS REMEDIED WITH MINIMAL DELAY THROUGH THE USE OF THE SECOND INSTRUMENT SET. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10427348 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF ONE (1) FEMORAL RECONSTRUCTION NAIL, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE, TWO (2) PROXIMAL LOCKING SCREW, TWO (2) DISTAL LOCKING SCREW AND TEN (10) UNKNOWN SCREWS DUE TO POSSIBLE INFECTION. THE PATIENT STATUS AND PROCEDURE OUTCOMES ARE UNKNOWN. THIS IS REPORT 02 OF 06 OF (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9700115 ↗
• InjuryJul 9, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON JUNE 11, 2019, THE PATIENT UNDERWENT REMOVAL OF FIVE (5) VARIABLE ANGLE LOCKING SCREWS (REMOVED FROM THE DISTAL END OF PLATE), ONE (1) VARIABLE ANGLE LOCKING NAVICULAR PLATE, AND SIX (6) CORTEX SCREWS DUE TO NONUNION/MALUNION. A VARIABLE ANGLE LOCKING COMPRESSION PLATE CURVED CONDYLAR PLATE WAS REMAINED IMPLANTED BECAUSE IT WAS HOLDING LATERAL LENGTH OF THE FRACTURE. ORIGINALLY, THE PATIENT HAD A DISTAL FEMUR FRACTURE TREATED WITH VA CONDYLAR PLATE AND VA NAVICULAR PLATE ON AN UNKNOWN DATE. THE ANATOMY RESTORED AND FIXED WITH ZIMMER MEDIAL PLATE. THE VARIABLE ANGLE DISTAL FEMUR PLATE REAPPLIED WITH NEW FIVE (5) SCREWS. IT WAS FURTHER REPORTED THAT THE FIVE (5) CORTEX SCREWS REMAINED IN THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5 MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301 MM/RIGHT THIS IS REPORT 1 OF 5 FOR (B)(4).

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

  MAUDE report 8771225 ↗
• InjuryMay 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF ONE (1) VARIABLE ANGLE - LOCKING COMPRESSION PLATE (VA-LCP) CURVED CODYLAR PLATE, FOUR (4) 4.5MM CORTEX SCREW AND THREE (3) 3.5MM CORTEX SCREW DUE TO NONUNION. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 8644207 ↗
• MalfunctionFeb 14, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AN UNKNOWN INTERLOCKING BOLT WOULD NOT SCREW INTO THE VARIABLE ANGLE (VA) PLATE CURVED CONDYLAR PLATE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON (B)(6) 2019. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER PLATE. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8340793 ↗
• InjuryOct 15, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF A BROKEN VARIABLE ANGLE CURVED CONDYLAR PLATE OF THE DISTAL FEMUR ON AN UNKNOWN DATE. THE DEVICE WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. ALONG WITH THE CONDYLAR PLATE, THE SIX (6) UNKNOWN VARIABLE ANGLE CANNULATED LOCKING SCREW, FOUR (4) UNKNOWN VARIABLE ANGLE LOCKING SCREW, AND TWO (2) UNKNOWN CORTEX SCREWS WERE ALSO REMOVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 5.0 VARIABLE ANGLE CANNULATED LOCKING SCREW (PART/LOT UNKNOWN, QUANTITY 6), 5.0 VARIABLE ANGLE LOCKING SCREW (PART/LOT UNKNOWN, QUANTITY 4), 4.5 CORTEX SCREWS (PART/LOT UNKNOWN, QUANTITY 2). THIS REPORT IS FOR A VARIABLE ANGLE CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7964903 ↗
• InjuryJan 4, 2018Break; Break

  IT WAS REPORTED THAT PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION REVISION ON (B)(6) 2017 FOR A BROKEN PLATE AND NONUNION. IT IS UNKNOWN THE EXACT DATE OF IMPLANTATION BUT IT IS THOUGHT THAT IT WAS SOMETIME IN (B)(6) 2017. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A POSITIVE PATIENT OUTCOME. CONCOMITANT DEVICE(S) REPORTED: SCREWS (PART/LOT UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Impaired Healing

  MAUDE report 7164067 ↗
• InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, WITH A HISTORY OF VASCULAR DISEASE AND A PREVIOUS LEFT LEG AMPUTATION, WAS INITIALLY IMPLANTED WITH A RIGHT FEMUR PLATE, TEN SCREWS AND TWO CABLES ON (B)(6) 2014. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2017 FOR AN ABOVE THE KNEE AMPUTATION DUE TO ISCHEMIA OF HER RIGHT FOOT. IT WAS REPORTED THAT THE HARDWARE WAS BEING REMOVED BECAUSE THEY WERE IN THE WAY OF THE AMPUTATION AND NOT FELT TO BE A CAUSE OF THE ISCHEMIA. THE HARDWARE WAS INTACT AND THE PLATE AND SCREWS WERE EASILY REMOVED. IT WAS REPORTED THAT THE TWO CABLES WERE GOING TO BE REMOVED WITH THE AMPUTATED LEG. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT. THIS IS REPORT 1 OF 13 FOR (B)(4).

  Patient problems: Ischemia; No Code Available

  MAUDE report 6420643 ↗

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