VA-LCP 02.124.417Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982042958), received between Jun 13, 2018 and Feb 21, 2025 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE 4.5 VA CONDYLAR PLATE WAS BROKEN IN THE SHAFT PART OF THE PLATE. ANOTHER OPERATION WAS REQUIRED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21437268 ↗
• InjurySep 6, 2024Off-Label Use; Off-Label Use

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 14 PATIENTS THAT WERE IMPLANTED WITH 3.5/4.5 MM VA-LCP PERIPROSTHETIC PROXIMAL FEMUR PLATING SYSTEM. IMPLANTATION WAS BETWEEN DECEMBER 2021 TO APRIL 2024 AT WAKE FOREST UNIVERSITY HEALTH SYSTEMS. PATIENT NUMBER 10 (56-YEAR-OLD FEMALE) - HISTORY OF DDD, ANKLE ARTHRITIS, LUMBAR RADICULOPATHY & SPONDYLOSIS. IMPLANTS WERE PLACED DUE TO PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. POST-OP COMPLICATION FOR POST-OP WOUND INFECTION AND DEHISCENCE. THIS IS RELATED TO THE PROCEDURE. TREATMENT INCLUDED SURGICAL INTERVENTION AND ANTIBIOTICS. THE PATIENT REPORTED USING THE DISTAL SPANNING ATTACHING PLATE (DSAP) WITH THE DEPUY CURVE CONDYLAR PERIARTICULAR PLATE FOR A PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. THE DSAP WAS NOT DESIGNED FOR USAGE WITH THIS PARTICULAR PLATE; THUS, THIS CASE WAS CONSIDERED OFF-LABEL.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 20158220 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE INVOLVED THE REMOVAL OF THE VA CONDYLAR PLATE AND RETROGRADE FEMORAL NAILING SYSTEM (RFNA) DUE TO NON-UNION OF THE FEMUR. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19354654 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON THEN ADDRESSED THE NONUNION SITE, AND PLACED 2 NEW PLATES ONTO THE PATIENT'S FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN PATIENT'S FEMUR. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT. THIS IS REPORT 4 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16896987 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD A FALL AND SUSTAINED A PERIPROSTHETIC FEMUR FRACTURE REQUIRING OPEN REDUCTION INTERNAL FIXATION (ORIF). THE PLATE AND SCREWS WERE MANUFACTURED BY SYNTHES. IMPLANTS DID NOT APPEAR TO BE REMOVED. ON (B)(6) 2021, X-RAY TAKEN SHOWED PERSISTENT DISPLACEMENT OF A PARTIALLY HEALED DISTAL FEMUR FRACTURE WITH LATERAL PLATE AND SCREW CONSTRUCT STABLE IN POSITION. ON (B)(6) 2021, INJECTION TO LEFT KNEE FOR PAIN PERFORMED. PAIN HAS PERSISTED DESPITE PHYSICAL THERAPY, BRACING, AND NERVE BLOCKS. ON (B)(6) 2021, SURGEON STATED, THAT THE LEFT KNEE IS LIGAMENTOUSLY LOOSE TO VARUS STRESS AND PAIN. ON (B)(6) 2021, X-RAY RESULTS STATED, THAT THERE IS A PERIPROSTHETIC FRACTURE IN THE DISTAL FEMORAL DIAPHYSIS, THAT IS SUBACUTE TO CHRONIC. THERE IS ONE SHAFT WIDTH POSTERIOR DISPLACEMENT OF THE DISTAL FRACTURE FRAGMENT. THERE IS NO EVIDENCE OF HARDWARE FRACTURE OR LOOSENING. SURGEON STATES, LEFT KNEE IS UNSTABLE LIKELY SECONDARY TO MALUNION OF THE FEMUR FRACTURE WITH RESULTANT SHORTENING. ON (B)(6) 2021, PATIENT SUSTAINED TWO FALLS RESULTING IN A PELVIC AND THEN A RIGHT HUMERAL FRACTURE. MEDICAL RECORDS DO NOT INCLUDE THE PRIMARY OPERATIVE NOTES, NOR TH

  Patient problems: Bone Fracture(s); Malunion of Bone; Pain

  MAUDE report 16747872 ↗
• InjuryJun 23, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DISTAL FEMUR FRACTURE WILL BE REVISED ON (B)(6)2022. THE PLATE BROKE AT THE FRACTURE SITE. THE DATE OF ORIGINAL SURGERY IS CURRENTLY UNKNOWN. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES (1) DEVICE 4.5 VA-LCP CRVD COND PL/16 HOLE/336/LFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14790920 ↗
• InjuryMay 7, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THERE WAS NON-UNION DISTAL FEMUR WITH BROKEN SYNTHES VA CONDYLAR PLATE CONSTRUCT. THE PLAN WAS TO REMOVE THE REMOVE CONSTRUCT AND *RIA2 AND REVISE WITH STRYKER NAIL + PLATE HYBRID CONSTRUCT. ALL IMPLANTS WERE EXPLANTED. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: CORTEX: TRAUMA ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 4) UNK - SCREWS: LOCKING: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 7) THIS COMPLAINT INVOLVES ONE (1) DEVICE 4.5 VA-LCP CRVD COND PL/16 HOLE/336/LFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14319882 ↗
• InjuryApr 4, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE 4.5 VA CURVED CONDYLAR PLATE BROKE. PLATE REMOVAL AND REVISION SURGERY WAS DONE. PROCEDURE OUTCOME UNKNOWN. PATIENT CONSEQUENCE UNKNOWN. THIS COMPLAINT INVOLVES (1) DEVICE 4.5 VA-LCP CRVD COND PL/16 HOLE/336/LFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14000368 ↗
• MalfunctionJan 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREADS DID NOT PROPERLY SEAT WITH THE AIMING ARM JIG CAUSING IT TO NOT PROPERLY WORK WITH THE JIG. THE PLATE DID NOT CONNECT TO THE AIMING ARM DESIGNED FOR USE WITH THE PLATE. A NEW PLATE WAS OPENED AND USED FOR IMPLANTATION. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254205 ↗
• InjurySep 2, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREWS BACKED OUT OF THE VA LCP CURVED CONDYLAR PLATE. THE PATIENT REQUIRED REVISION SURGERY ON (B)(6) 2020 TO REMOVE HARDWARE. THERE WAS PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10486053 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO NON-UNION, REAMER IRRIGATOR ASPIRATOR (RIA) BONE GRAFT HARVEST, RIA BONE GRAFT APPLICATION INTO THE NONUNION SITE. THE ORIGINAL DATE OF IMPLANTATION WAS UNKNOWN. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME NON-UNION. THIS REPORT IS FOR 1 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4). THIS EVENT INVOLVES TOTAL 15 DEVICES. THIS COMPLAINT REPORTS 10 DEVICES, REAMING DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10273579 ↗
• InjuryMay 18, 2020Break; Break

  IT WAS REPORTED THAT INITIALLY ON (B)(6) 2018, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT FEMUR DUE TO A COMMINUTED FRACTURE OF THE MIDSHAFT. THE PATIENT HAS A BOOT ON THE RIGHT LEG FOR ANOTHER ORTHOPEDIC ISSUE IN WHICH THE VELCRO OF THE BOOT GOT STUCK ON THE RECLINER HANDLE CAUSING HER TO FALL TWISTING HER LEFT LEG. THE PATIENT HAD PAIN AND INABILITY TO AMBULATE AFTERWARD AND WAS BROUGHT TO THE EMERGENCY DEPARTMENT. THE FRACTURE WAS STABILIZED USING (1) 4.5MM VARIABLE ANGLE- LOCKING COMPRESSION PLATE CURVED CONDYLAR PLATE 16 HOLES, LEFT, 336MM, (6) SYNTHES 1.7MM CERCLAGE CABLES AND (12) SYNTHES SCREWS. SHE TOLERATED THE PROCEDURE WELL, WAS AWAKENED, TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. THE PATIENT WAS THEN TAKEN TO A SKILLED NURSING FACILITY AFTER DISCHARGE WHERE SHE SPENT 2 AND HALF MONTHS COMPLETING INPATIENT REHAB. AFTERWARD, SHE WAS RELEASED TO HOME WHERE SHE THEN SPENT ANOTHER MONTH WORKING WITH A HOME HEALTH PHYSICAL THERAPIST (2 TIMES PER WEEK) AND LATER WAS ASKED TO PROGRESS TO OUTPATIENT THERAPY. SHE HAS BEEN DOING WELL IN HER RECOVERY WITH INCREASING MOBILITY AND WITH NO PAIN IN THE LEFT THIGH. RADIOGRAPHS PERFORMED ON (B)(6)

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 10066277 ↗
• InjuryOct 29, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WENT FOR A BROKEN HARDWARE REMOVAL SURGERY. A 4.5 MM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CURVE CONDYLAR PLATE WAS BROKE. A PATIENT WAS INVOLVED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY, PROCEDURE COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS FINE. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9251896 ↗
• InjuryJan 22, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A NON-UNION AND BROKEN VARIABLE ANGLE LCP CURVED CONDYLAR PLATE AT THE SITE OF THE ORIGINAL FRACTURE, WHICH WAS DIRECTLY BELOW THE TOTAL HIP PROSTHESIS. THE SURGEON REMOVED THE BROKEN PLATE, SIX (6) UNKNOWN SCREWS, AND TWO (2) UNKNOWN CABLES. HE REPLACED THE HIP PROSTHESIS WITH A LONGER PROSTHESIS TO SECURE THE FRACTURE. THE PATIENT ORIGINALLY HAD A LEFT FEMUR PERI-PROSTHETIC FRACTURE IN (B)(6) 2018. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 6); UNK - CABLE ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8267989 ↗
• InjurySep 11, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A NON-UNION FRACTURE IN THE DISTAL FEMUR. THE VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE BROKE AT THE FRACTURE SITE AND WAS REMOVED. A NEW PLATE WAS PLACED ALONG THE DISTAL FEMUR ALONG WITH A RETROGRADE FEMORAL NAIL IN CANAL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE/S REPORTED: UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 7866029 ↗
• InjuryJun 13, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH A TOTAL KNEE PROSTHETIC. THE PATIENT WAS IMPLANTED WITH (1) LCP CURVED CONDYLAR PLATE, (6) VARIABLE ANGLE LOCKING SCREWS, (4) CORTEX SCREWS SELF-TAPPING, (1) 1.0MM CABLE WITH CRIMP, AND (5) 1.7MM CABLE WITH CRIMP. ON AN UNKNOWN DATE THE PATIENT IS REPORTED AS HAVING PAIN. ON A FOLLOW-UP VISIT IT WAS DISCOVERED THAT THE 16 HOLE CONDYLAR PLATE BROKE ON THE LATERAL SIDE OF THE TOTAL KNEE WHERE THE SPIKE FROM MET THE PLATE. ALL OTHER IMPLANTS WERE REMOVED INTACT. THE REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2018. THE PATIENT WAS REVISED WITH A NEW PLATE. THERE IS NO REPORT OF PATIENT HARM AND SURGERY COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES: 4 QTY, P/N 214.822, L/N UNKNOWN; 6 QTY, P/N 02.231.218, L/N UNKNOWN; 1 QTY, P/N 298.800.01S, L/N UNKNOWN; 5 QTY, P/N 298.801.01S, L/N UNKNOWN/ THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: Pain

  MAUDE report 7596850 ↗

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