VA-LCP 02.124.408Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982042774), received between Jul 17, 2017 and Jun 8, 2023 — classified as 10 injuries, 2 malfunctions.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT A VA CONDYLAR PLATE AND SCREW CONSTRUCT WITH NON-SYNTHES CABLES IN (B)(6) OF 2022. ON (B)(6)2023, A REMOVAL SURGERY AND DISTAL FEMUR REPLACEMENT WAS PERFORMED DUE TO NONUNION. THE CONSTRUCTS WERE SUCCESSFULLY REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17085437 ↗
• MalfunctionFeb 2, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE ALLEGED IMPLANTS WERE STRIPPED WHEN TRYING TO ATTACH THE AIMING ARM. THE HANDLES FOR THE MULTI WIRE GUIDE DID NOT FULLY CONNECT TO THE MULTIPLE WIRE GUIDE AND PARALLEL GUIDE, GETTING STUCK BEFORE FULLY CONNECTING, DAMAGING THE GUIDES. MULTIPLE SETS WERE OPENED TO SEE IF IT THERE WAS A SOLUTION, THE STANDARD GUIDE FROM THE 6.5/7.3 CANNULATED SET WAS ULTIMATELY USED. A TNA WAS PERFORMED AND THE DRILL BIT HIT THE NAIL AFTER USING THE COMPRESSION FEATURE, DEPTH GAUGE WAS BENT FROM USAGE AND FADED. THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16285960 ↗
• InjuryDec 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TO OPERATING ROOM ON (B)(6) 2022 FOR REMOVAL AND REVISION OF NONUNION DISTAL FEMUR FRACTURE. IMPLANT WAS PLACED OVER TWO YEARS AGO. THERE WAS PATIENT CONSEQUENCE WHICH IS NONUNION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CURVED COND PL/8 HOLE/195/RT. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16080315 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING POST-OP EVENT BILATERAL REVISION OF FEMUR FIXATION DONE DUE TO NON-UNION AND MAL-REDUCTION THERE WERE PATIENT CONSEQUENCES. RIGHT SIDE: REMOVAL OF FOUR (4) SCREWS FROM A PLATE, COMPRESSION APPLICATION AND RE-INSERTION OF NEW SCREWS INTO EXISTING PLATE WAS DONE. LEFT SIDE: REMOVAL OF RETROGRADE FEMORAL NAIL WITH THREE (3) SCREWS AND NEW IMPLANTATION OF NAIL WITH COMPRESSION PLATING WAS DONE. ONE SCREW WAS BROKEN. THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT. THIS IS REPORT 1 OF 5 FOR (B)(4).

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

  MAUDE report 15027159 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A SYNTHES VA(VARIABLE ANGLE) DISTAL FEMUR PLATE AND SCREWS WILL BE REMOVED. THE FRACTURE RE-REDUCED AND REVISED ON (B)(6) 2021. THE REASON IS A FAILED PERI PROSTHETIC FRACTURE AND THE HARDWARE WAS REMOVED COMPLETELY. THIS REPORT IS FOR (1) 4.5 VA-LCP CURVED COND PL/8 HOLE/195/RT. THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 12712072 ↗
• InjuryApr 12, 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 HARDWARE REMOVAL FOLLOWED BY OSTEOTOMY CORRECTION WITH NAIL DUE TO MALUNION. INITIALLY, THE PATIENT WAS IMPLANTED WITH VARIABLE ANGLE (VA) CONDYLAR PLATE. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME UNKNOWN. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) 4.5 VA-LCP CURVED COND PL/8 HOLE/195/RT. THIS REPORT IS 1 OF 10 (B)(4). (B)(4) CAPTURES THE 10 OF 12 DEVICES WAS LINKED TO (B)(4) THAT CAPTURES THE REMAINING 2 OF 12 DEVICES.

  Patient problems: Malunion of Bone

  MAUDE report 11651529 ↗
• MalfunctionAug 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE DISCOVERED AS DAMAGED AFTER THE SALES CONSULTANT RECEIVED THE ITEM SHIPMENTS. MULTIPLE PACKAGES WERE BROKEN WITH THE SCREWS REPORTED AS FLATTENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10448770 ↗
• InjuryMay 22, 2019Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5085793. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. CONCOMITANT REPORTED: SCREWS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 11). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8633827 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD UNDERGONE REMOVAL OF HARDWARE AND REVISION SURGERY DUE TO NONUNION AND DELAYED HEALING. ORIGINAL DATE OF IMPLANT PROCEDURE WAS DONE ON (B)(6) 2018 AT AN OUTSIDE FACILITY FOR A SEGMENTAL FEMUR FRACTURE. THE SURGEON AT THAT TIME USED AN UNKNOWN LATERAL ENTRY FEMORAL NAIL (LEFN) AND A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE TO TREAT THE FRACTURE. ALL DEVICES WERE REMOVED SUCCESSFULLY. A RETROGRADE NAIL WAS INSERTED FOR THE REVISION PROCEDURE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED AND PATIENT OUTCOME IS GOOD. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT. THIS REPORT IS 1 OF 6 FOR (B)(4).

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

  MAUDE report 8215187 ↗
• InjuryMay 11, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON AN UNKNOWN DATE DUE TO A POLYTRAUMA. AFTER THE SURGERY, THE PATIENT WAS REPORTED TO BE NONCOMPLIANT AND WALKED EARLIER THAN INSTRUCTED BY THE SURGEON. A NONUNION OF THE DISTAL FEMUR FRACTURE OCCURRED AND X-RAYS WERE TAKEN OF THE DISTAL FEMUR. THE PLATE WAS FOUND TO BE BROKEN ALONG THE SHAFT AND ONE LOCKING SCREW WAS BROKEN JUST BELOW THE HEAD OF THE SCREW. NO FRAGMENTS WERE GENERATED FROM THE BROKEN PARTS. ALL ORIGINAL HARDWARE (THE PLATE, AN UNKNOWN NUMBER OF LOCKING SCREWS AND UNKNOWN NUMBER OF CORTEX SCREWS) WAS REMOVED ON (B)(6) 2018 AND REPLACED WITH AN AUTOGRAPH USING RIA (REAMER IRRIGATOR/ASPIRATOR), A RETROGRADE NAIL WITH A SPIRAL BLADE, A DISTAL INTERLOCKING SCREW AND TWO PROXIMAL INTERLOCKING SCREWS. REVISION COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT PRODUCTS: LOCKING SCREWS (PART/LOT UNKNOWN, QUANTITY UNKNOWN), CORTEX SCREWS (PART/LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7506162 ↗
• InjuryMar 9, 2018Break; Break

  CUSTOMER QUALITY UNIT RECEIVED A MAUDE REPORT FORWARDED FROM DEPARTMENT OF HUMAN SERVICES; THIS REPORT IS AGAINST USER FACILITY REPORT MW5074624. ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. A COPY OF THE MAUDE EVENT REPORT IS ATTACHED. IT WAS REPORTED THAT ON AN UNKNOWN DATE APPROXIMATELY THREE YEARS AGO, PATIENT WAS IMPLANTED WITH ONE (1) UNKNOWN TOTAL KNEE ARTHROPLASTY (TKA) CONSTRUCT (MANUFACTURER UNKNOWN). ON (B)(6) 2016, PATIENT UNDERWENT IMPLANT PROCEDURE TO TREAT LOSS STRESS FEMURE FRACTURE. PATIENT WAS IMPLANTED WITH ONE 4.5 MM (1) VARIABLE ANGLE (VA) CURVED CONDYLAR PLATE, EIGHT (8) 5.0 MM VA LOCKING SCREWS, ONE (1) 5.0 MM CANNULATED VA LOCKING SCREW, ONE (1) 4.5 MM CORTEX SCREW. SUBSEQUENTLY, ON AN UNKNOWN DATE, JUST FIFTY-ONE (51) DAYS AFTER THE PATIENT BEING RELEASED TO A FULL WEIGHT BEARING STATUS, THE PLATE BROKE AND THE PATIENT DEVELOPED A NONUNION AND THE BONE HAD RE FRACTURED. ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY. THE SURGEON WENT INTO SURGERY WITH THE PLAN TO NOT REMOVE THE IMPLANTS, BUT SUBSEQUENTLY, ENDED UP REMOVING ALL IMPLANTS. THE SURGEON CUT OUT THE TISSUE SURROUNDING THE PLATE AND THE PLATE WAS STILL STUCK.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7327531 ↗
• InjuryJul 17, 2017Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2017 DUE TO A BROKEN 8-HOLE DISTAL FEMUR PLATE AND FEMUR NON-UNION. THE ORIGINAL PROCEDURE WAS PERFORMED IN (B)(6) 2016. SUBSEQUENTLY, IT WAS DISCOVERED THAT THE PLATE HAD BROKEN IN TWO PLACES. THE REMOVED HARDWARE INCLUDED: ONE (1) 4.5MM VARIABLE-ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT (WHICH HAD BROKEN IN TWO PLACES), AND TEN (10) 5.0MM LOCKING STARDRIVE SCREWS (ALL INTACT). THE BREAKS ON THE PLATE OCCURRED AT THE SIXTH DISTAL ANTERIOR HOLE AND THE SEVENTH DISTAL COMBI HOLE ON THE VA POSTERIOR LOCKING SIDE. THE PATIENT WAS REVISED TO A FEMORAL NAIL. THERE WERE NO REPORTED SURGICAL DELAYS, NO FRAGMENTS INVOLVED AND NO ADDITIONAL X-RAYS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: UNKNOWN 5.0MM LOCKING STARDRIVE SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 10). THIS REPORT IS 1 OF 1 FOR (B)(4).

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

  MAUDE report 6718055 ↗

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