VA-LCP 02.124.413Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982042873), received between Dec 15, 2016 and Mar 31, 2026 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Device-Device Incompatibility

  IT WAS REPORTED THE PLATE HOLE WOULD NOT ACCEPT LOCKING SCREW. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746040 ↗
• MalfunctionMay 3, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PLATE STRIPPED DURING ATTACHMENT OF AIMING ARM WITH WRENCH. THE OPERATOR WAS BENT DURING PROCESS DUE TO PRESSURE. RFNA AIMING ARM WAS CRACKED DURING MALLEATING. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864597 ↗
• MalfunctionJan 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, AN EVENT OCCURRED WHERE WE DID A NAIL PLATE COMBO, THE FIRST PLATE WAS USED THE CENTRAL FIXED ANGLE SCREW HOLE DID NOT LOCK INTO THE PLATE, WE ENDED UP TAKING OUT THE PLATE AND USING A SECOND ONE OF A LONGER LENGTH. WE ASSEMBLED THE NAIL AND THEN INSERTED THE LM / ML SCREW HOLES AND THE DRILL BIT MISSED THE NAIL, I¿M NOT ENTIRELY SURE IF IT WAS DUE TO THE NOTCH OF THE TKA REPLACEMENT OR BECAUSE OF THE SCREWS FROM THE PLATE DIVERGING THE DRILL BIT. THE 13MM SLEEVE WAS BENT DURING THE CASE AS WELL FROM PUSHING AND THE ENTRY REAMER WAS STUCK IN THE SLEEVE. (B)(4) IS RELATED TO (B)(4). (B)(4) CAPTURES POST-OP. (B)(4) CAPTURES INTRA-OP. THIS COMPLAIN INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250628 ↗
• InjuryJul 21, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT SUSTAINED PERIPROSTHETIC FRACTURE (PPF) BELOW FEMORAL NAIL IN (B)(6) AND WAS FIXED WITH VA CONDYLAR PLATE ON AN UNKNOWN DATE IN (B)(6) 2022. PATIENT WAS READMITTED APPROXIMATELY 3 MONTHS AFTER IMPLANT WITH PLATE FRACTURE. NO NEW TRAUMA. HAD BEEN MOBILIZING IN RESIDENTIAL HOME. NORMAL TO LOW BMI. FRACTURE NON-UNITED, BUT NO EVIDENCE OF INFECTION. REVISION OCCURRED (B)(6) 2022. THIS IS REPORT 1 OF 11 FOR (B)(4). THIS REPORT IS FOR A VA-LCP CONDYLAR PLATE. THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15074845 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REMOVAL OF THE VARIABLE ANGLE (VA) CONDYLE PLATE AND CORRESPONDING SCREWS DUE TO NONUNION/MALUNION. THE SURGEON REMOVED THE PLATE AND SCREWS, REALIGNED THE FEMUR, INSERTED IM NAIL, AND INSERTED BONE GRAFT OBTAINED VIA RADIOIMMUNOASSAY (RIA) PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT. THIS IS REPORT 1 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14654053 ↗
• InjuryFeb 26, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION SURGERY DUE TO NON-UNION AND IMPLANT FAILURE. PATIENT SUSTAINED AN OPEN DISTAL FEMUR FRACTURE AND WAS TREATED WITH A 4.5MM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE ON (B)(6) 2019. THE FRACTURE WENT ON TO NON-UNION AND THE PLATE SUBSEQUENTLY BROKE AT THE NON-UNION SITE. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM (OR) ON (B)(6) 2021 FOR HARDWARE REMOVAL (ALL HARDWARE WAS REMOVED UNEVENTFULLY) AND INSERTION OF RETROGRADE FEMORAL NAIL. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME IS UNKNOWN. THE COMPLAINT (B)(4) WILL CAPTURE THE EXCESS IMPACTED PRODUCT WITH THE CORRESPONDING PART # 02.231.275 OF COMPLAINT (B)(4) DUE TO LIMITATION OF 10 IP'S PER COMPLAINT. CONCOMITANT DEVICES REPORTED: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT, 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/36MM, 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/38MM, 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/70MM, 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/75MM, 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/34MM, 4.5MM CORTEX SCREW SELF-TAPPING 34MM. THI

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11386460 ↗
• InjuryApr 17, 2020Adverse 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 UNDERWENT REAMER/ IRRIGATOR/ ASPIRATOR (RIA) BONE HARVEST AND A REVISION OF DEVICES DUE TO A FAILED FIXATION DISTAL FEMUR FRACTURE. THE PATIENT ORIGINALLY IMPLANTED WITH VARIABLE ANGLE CONDYLAR PLATE 12 HOLE LEFT AND SCREWS ON AN UNKNOWN DATE. THE PLATE AND SCREWS WERE EXPLANTED. IT WAS REVISED TO ZIMMER RETROGRADE FEMORAL NAIL AND ALSO WITH A DUAL FIXATION WITH SYNTHES VA CONDYLAR PLATE 22 HOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS STABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. (B)(4).

  Patient problems: Injury

  MAUDE report 9974836 ↗
• InjuryMar 26, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF THE VARIABLE ANGLE (VA) CONDYLAR PLATE FOR A DISTAL FEMUR REPLACEMENT DUE TO NON-UNION OF A PERIPROSTHETIC DISTAL FEMUR FRACTURE. DURING THE REMOVAL PROCEDURE, THE DISTAL THIRD OF FEMUR WAS RESECTED AND SURGEON REMOVED PLATE CONNECTED TO THE RESECTED BONE. IT WAS ALSO DISCOVERED DURING THE CASE THAT ONE 4.5 CORTEX SCREW WAS BROKEN. IT IS UNKNOWN IF THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW CORTEX (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN SCREW-TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT THIS IS REPORT 1 OF 3 FOR (B)(4). (B)(4) WILL CAPTURE THE POST-OP EVENT WHERE THE PATIENT UNDERWENT A REMOVAL PROCEDURE DUE TO NON-UNION OF A PERIPROSTHETIC DISTAL FEMUR FRACTURE, (B)(4) WILL CAPTURE THE INTRA-OP EVENT WHERE THE SURGEON PERFORMED A RESECTION TO REMOVE THE THE VA-LCP PLATE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9883741 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION LEFT DISTAL FEMUR FRACTURE DUE TO DEFORMITY AND PAIN IN THE LEFT THIGH SUSTAINED FROM A FALL WHILE ON VACATION. X-RAYS AND CT REVEALED AN INTRA-ARTICULAR FRACTURE INVOLVING THE LEFT FEMUR. THE PATIENT WAS IMPLANTED WITH DEPUY SYNTHES IMPLANTS. POSTOPERATIVELY, ON (B)(6) 2016, RADIOGRAPHS SHOW A HEALING FRACTURE POST PLATE AND SCREW OSTEOSYNTHESIS. INTERVAL CALLUS FORMATION IS NOTED WITH ACCEPTABLE ALIGNMENT BUT STILL HAS DELAYED UNION. NO HARDWARE COMPLICATIONS OR OTHER ACUTE FINDINGS. ON (B)(6) 2017, THE PATIENT'S CONDITION WAS GETTING IMPROVEMENT AND WAS ABLE TO AMBULATE W/ ASSISTANCE OF A CANE. UNFORTUNATELY, HE SLIPPED ON A WET CEMENT FLOOR AND HAD A FALL AND INJURED THE LEFT KNEE. HE HEARD A POP AT THE KNEE AND SINCE THEN HE HAD SEVERE PAIN AND HAS BEEN UNABLE TO PLACE WEIGHT ON HIS LEFT LOWER EXTREMITY. ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION OF DISTAL LEFT FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH BONE GRAFTING AND LATERAL PLATE AND SCREW FIXATION FOR FRACTURE NONUNION. PREOPERATIVELY, IMAGES REVEALED A DISPLACED DISTAL FEMUR FRACTURE NONUNION WITH BROKEN HARDWARE. T

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

  MAUDE report 9617984 ↗
• MalfunctionDec 9, 2019Material Deformation; Material Deformation

  UPDATED CONCOMITANT DEVICE: UNKNOWN PERCUTANEOUS AIMING ARM ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY#1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437298 ↗
• MalfunctionFeb 27, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON NOTED THAT THE CANNULATED VARIABLE LOCKING SCREW DID NOT LOCK INTO DISTAL HOLE AND THE SURGEON ALSO MENTIONED IT MAY HAVE STRIPPED THE THREADS ON THE VARIABLE ANGLE- LOCKING CONDYLAR PLATE DURING SCREW INSERTION. FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR A VARIABLE ANGLE- LOCKING CONDYLAR PLATE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8374750 ↗
• InjuryJan 19, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT HAD A 13 HOLE 4.5 (VARIABLE ANGLE LOCKING PLATE)VA-LCP CONDYLAR PLATE 02.124.413 LOT#L020868 IN (B)(6) 2017. PATIENT REPORTED TO OPERATING ROOM WITH COMPLAINT OF PAIN. X-RAY SHOWED THE PLATE HAD BROKEN BETWEEN THE 3RD AND 4TH SHAFT HOLE DISTALLY DUE TO A DELAYED NON UNION. PLATE WAS REMOVED ON (B)(6) 2017 AND REPLACED WITH A RAFN (RETROGRADE ANTEROGRADE FIXAION NAIL) NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY.NO COMPLICATIONS WERE REPORTED. THIS COMPLAINT IS FOR ONE DEVICE THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 7207006 ↗
• InjuryDec 18, 2017Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION OF ONE (1) BROKEN DISTAL FEMUR PLATE, FOUR (4) UNKNOWN CORTEX SCREWS, AND FIVE (5) UNKNOWN VA CANNULATED LOCKING SCREWS WAS PERFORMED ON (B)(6) 2017. THE ORIGINAL OPEN REDUCTION AND INTERNAL FIXATION OF DISTAL FEMUR WAS PERFORMED IN THE MONTH OF (B)(6) AND THE PATIENT WAS SUBSEQUENTLY DISCOVERED TO A HAVE A NON-UNION DUE TO A BROKEN DISTAL FEMUR PLATE. THE SURGEON REMOVED THE BROKEN PLATE, FOUR CORTEX SCREWS, AND FIVE VA CANNULATED LOCKING SCREWS. ALL THE SCREWS WERE REMOVED INTACT. THE PATIENT WAS REVISED TO A NEW DISTAL FEMUR PLATE AND SCREWS. THE REVISION SURGERY WAS PERFORMED UNEVENTFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS AS EXPECTED. CONCOMITANT DEVICES REPORTED : UNKNOWN CORTEX SCREWS (UNKNOWN PART AND LOT NUMBER, QUANTITY # 4), UNKNOWN VA CANNULATED LOCKING SCREWS (UNKNOWN PART AND LOT NUMBER, QUANTITY # 5). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Not Applicable

  MAUDE report 7126581 ↗
• InjuryDec 15, 2016Break; Break

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CURVED CONDULAR 12 HOLE PLATE, THREE (3) VA LOCKING SCREWS, ONE (1) 5.0MM FULL THREADED CANNULATED CONICAL SCREW, AND SIX (6) 3.5MM CORTEX SCREWS TO REPAIR A DISTAL FEMUR FRACTURE ON AN UNKNOWN DATE. POSTOPERATIVELY, ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE PLATE HAD BROKEN. ON AN UNKNOWN DATE, THE PATIENT WAS RETURNED TO THE OPERATING ROOM TO REMOVE THE BROKEN DEVICE AND IMPLANTED SCREWS. THE PATIENT WAS REIMPLANTED WITH A NEW PLATE AND SCREWS. IT WAS CONFIRMED THAT THE PATIENT WAS WEIGHT BEARING AGAINST DOCTOR'S ORDERS. THIS COMPLAINT INVOLVES ONE (1) DEVICE: 4.5MM VA-LCP 12 HOLE PLATE WITH ONE PART DATA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: UNKNOWN VA LOCKING SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 3), UNKNOWN FULL THREADED CANNULATED CONICAL SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 1), AND UNKNOWN CORTEX SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 6). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6175585 ↗

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