VA-LCP 02.124.406Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982042736), received between Oct 5, 2017 and Aug 29, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A SURGEON REMOVED A DISTAL FEMUR PLATE AND SCREWS DUE TO POTENTIAL INFECTION. NO ALLEGATIONS WERE MADE AGAINST THE PLATE AND SCREW CONSTRUCT. PATIENT OUTCOME IS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15316387 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT HARDWARE REMOVAL OF TWO (2) VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CONDYLAR PLATE AND SIXTEEN (16) UNKNOWN LOCKING SCREWS DUE TO PAIN. ORIGINALLY, THE PATIENT HAD BILATERAL OSTEOTOMIES ON UNKNOWN DATE. HOWEVER, THE PATIENT WAS EXPERIENCING PAIN WHEN PERFORMING SQUATS. THUS, REMOVAL WAS DONE SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. (B)(4).

  Patient problems: Pain

  MAUDE report 9596258 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A PARTIAL REVISION OF TOTAL KNEE AND KNEE MANIPULATION, AND WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE, FOUR (4) 4.5MM CORTEX SCREWS, THREE (3) CANNULATED VA LOCKING SCREWS, AND TWO (2) 5.0MM CANNULATED VA LOCKING SCREWS ON UNKNOWN DATE IN 2016. ON UNKNOWN DATE PATIENT REPORTED PAIN AND STIFFNESS ASSOCIATED WITH THE IMPLANTS. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS NOT REVISED TO ANY ADDITIONAL HARDWARE AS THE FRACTURE HAD HEALED. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE. (B)(4).

  Patient problems: Pain

  MAUDE report 7328012 ↗
• InjuryOct 5, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY IN (B)(6) 2017 FOR TREATMENT OF A RIGHT DISTAL FEMUR FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 4.5MM(VA) VARIABLE ANGLE LOCKING COMPRESSION CURVED CONDYLAR PLATE AND EIGHT (8) SCREWS. OF THE EIGHT SCREWS, ONE (1) 4.5MM CORTEX SCREW WAS IMPLANTED AT THE SHAFT ON THE PLATE, AND SEVEN (7) 5.0MM VA LOCKING SCREWS WERE IMPLANTED IN OTHER PLATE HOLE SCREW POSITIONS. ON AN UNKNOWN DATE, POST-OPERATIVE, PATIENT PRESENTED WITH A BROKEN PLATE AND ONE BROKEN 4.5MM CORTEX SCREW. THE PLATE WAS BROKEN AT THE BROKEN CORTEX SCREW POSITION. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS AND REVISED THE PATIENT TO A LONGER VA LOCKING PLATE AND SCREWS. IT WAS REPORTED THAT ALL SCREWS, THE PLATE AND ANY FRAGMENTS WERE RETRIEVED. ALL IMPLANTS HAVE BEEN RETAINED BY THE HOSPITAL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED:5.0MM VA LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 7) THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 6915222 ↗

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