VA-LCP 02.124.411Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982042835), received between Jun 27, 2018 and Apr 12, 2023 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON 01/22/2020, AN X-RAY OF FEMUR REPORT AND REVEALED A CLOSED COMMINUTED SUPRACONDYLAR FRACTURE OF LEFT FEMUR WITH NONUNION. DOI: (B)(6) 2019; DOE: (B)(6) 2020; LEFT FEMUR THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT. THIS IS REPORT 14 OF 14 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16724072 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL REPLACEMENT. HARDWARE REMOVAL LEFT FEMUR DUE TO LEFT SUPRACONDYLAR/INTERCONDYLAR FEMORAL FRACTURE NONUNION, HARDWARE FAILURE AND OSTEOARTHRITIS LEFT KNEE. ON (B)(6) 2021 THE PATIENT UNDERWENT LEFT DISTAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHES LATERAL PLATE AND MULTIPLE CERCLAGE CABLES DUE TO LEFT DISTAL FEMUR COMMINUTED INTRA-ARTICULAR FRACTURE AND MORBID OBESITY. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A FALL. SHE WAS CLIMBING OVER SOMETHING LIKE A DOG GATE, TRIPPED AND FELL. SHE INITIALLY FELT PAIN IN HER LEFT KNEE. SHE WAS DIAGNOSED WITH A LEFT DISTAL FEMUR FRACTURE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CRVD COND PL/10 HOLE/230/LFT. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16723761 ↗
• 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/10 HOLE/230/LFT THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250630 ↗
• MalfunctionSep 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, WHEN THE CURVED CONDYLAR PLATE AND THE AIMING ARM WAS ATTACHED, IT WAS NOT ABLE TO ATTACH DUE TO THE STRIPPAGE OF THE SCREW HOLE OF THE PLATE. WHILE USING THE AIMING ARM ON THE NEW UNKNOWN PLATE, THE NEUTRAL SLEEVES WERE NOT CONNECTING TO THE HARPOON. THE PEDIATRIC AIMING ARM WAS OUTRIGGER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH (10) MINUTES DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) 4.5 VA-LCP CRVD COND PL/10 HOLE/230/LFT. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525845 ↗
• InjuryFeb 26, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE DUE TO A BROKEN VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE. THE PATIENT WAS ORIGINALLY IMPLANTED EIGHT (8) MONTHS AGO. THE VA-LCP CURVED CONDYLAR PLATE ALONG WITH THREE (3) CORTICAL SCREWS, FIVE (5) LOCKING SCREWS, AND ONE (1) NON-LOCKING SCREW WERE REMOVED AND REPLACED WITH A 2-HOLE LONGER PLATE. THE SURGERY WAS COMPLETED WITH NO HARM TO THE PATIENT. CONCOMITANT DEVICES: CORTEX SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 3), LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 5), SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9756676 ↗
• InjuryJan 23, 2020Break; Break

  IT WAS REPORTED THAT 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. THE PLATE WAS BROKEN. ALL SCREWS WERE REMOVED AS WELL AS THE BROKEN PLATE. IT WAS FOUND OUT THAT THERE WAS FIBROUS UNION TISSUE SEEN WITHIN THE COMMINUTED AREA AND AN ATTRITIONAL BONE LOSS CONSISTENT WITH ATROPHIC AREAS OF NONUNION AND WAS IMPLANTED WITH A 4.5 MM VALCP COND PLATE AND A 3.5 X 32MM SELF-TAP SCREW. INITIALLY 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)(

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

  MAUDE report 9622773 ↗
• InjuryJul 12, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF A BROKEN VARIABLE ANGLE -LOCKING COMPRESSION (VA-LCP) CURVED CONDYLAR PLATE. IT WAS REPORTED THAT THE FEMUR PLATE WAS IN A PATIENT FOR A YEAR AND THE PATIENT DID NOT HEAL. DURING THE REMOVAL, PATIENT UNDERWENT BONE GRAFTING AND WAS REVISED TO A NEW PLATE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: TRAUMA SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7682003 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION OF A VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE WAS PERFORMED ON (B)(6) 2018. THE PATIENT WAS IMPLANTED WITH ONE (1) VA-LCP CURVED CONDYLAR PLATE, TWO (2) 5 MM CANNULATED VA LOCKING SCREWS 25 MM, ONE (1) 5 MM CANNULATED VA LOCKING SCREWS 45 MM, ONE (1) 5 MM CANNULATED VA LOCKING SCREWS 50 MM, ONE (1) 5 MM CANNULATED VA LOCKING SCREWS 65 MM, ONE (1) 5 MM CANNULATED VA LOCKING SCREWS 70 MM, ONE (1) 4.5 MM CORTEX SCREW 36 MM AND THREE (3) 4.5 MM CORTEX SCREWS 38 MM ON (B)(6) 2018. SUBSEQUENTLY, AFTER THE PROCEDURE, THE PATIENT FELL AND RE-BROKE THE FEMUR RIGHT ABOVE THE PLATE. THE PATIENT WAS BROUGHT BACK TO THE SURGERY ON (B)(6) 2018, AND THE SURGEON TOOK OUT THE PLATE AND REVISED IT TO A NEW ONE. ALL THE OTHER IMPLANTED DEVICES WERE ALSO REMOVED ALONG WITH THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO DEVICE BROKE, SO NO FRAGMENTS WERE GENERATED FROM BROKEN DEVICE. NO OTHER MEDICAL INTERVENTION REQUIRED. PATIENT OUTCOME WAS NOT REPORTED. CONCOMITANT DEVICE (S) REPORTED: 5 MM CANNULATED VA LOCKING SCREWS 25 MM (PART # 02.231.625, LOT # UNKNOWN, QTY # 2), 5 MM CANNULATED

  Patient problems: Bone Fracture(s)

  MAUDE report 7641899 ↗

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