VA-LCP 02.124.420SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982043023), received between May 21, 2020 and May 21, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2020Break; Break

  UPDATED EVENT DESCRIPTION: ON (B)(6) 2017, PATIENT STATUS POST MECHANICAL FALL WITH COMPLAINTS OF RIGHT LEG PAIN AND INABILITY TO AMBULATE. RADIOGRAPHIC IMAGING IDENTIFIED A PERIPROSTHETIC FEMORAL SHAFT FRACTURE INDICATING THE PATIENT FOR THE AFOREMENTIONED SURGICAL STABILIZATION PROCEDURE. ON (B)(6) 2017, PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF FEMUR RIGHT SIDE, FIXATION WAS THEN OBTAINED WITH MULTIPLE CABLES MADE ALONG SYNTHES LATERAL PLATE. ON (B)(6) 2018, PATIENT WAS STILL HAVING PAIN AND X-RAYS REVEALED BROKEN PLATE AND FEMORAL NON-UNION. PATIENT HAD EVALUATION AND MANAGEMENT OF RIGHT HIP PAIN. SHE WAS SEEN BY SURGEON'S TEAM ON (B)(6) 2018 AND DISCUSSED REVISION ORIF VS PFR/REVISION ARTHROPLASTY. ON (B)(6) 2019 X-RAYS REVEALED THE PLATE IS BROKEN AS WELL AS CERCLAGE CABLES AT THE LEVEL OF THE FRACTURE SITE. THE HARDWARE OBSCURES PORTIONS OF THE FRACTURE ASSESSMENT OF THE DEGREE OF BONE BRIDGING IS DIFFICULT TO ASSESS. ALSO NOTED MILD VARUS ANGULATION AT THE FRACTURE LEVEL. ON (B)(6) 2019, THE PATIENT UNDERWENT TWO COMPONENT REVISION, RIGHT TOTAL HIP, RADICAL EXCISION OF PROXIMAL 21CM OF RIGHT FEMUR AND PROPHYLACTIC STABILIZATION OF DISTAL RIGHT FEMUR WITH PLAT

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

  MAUDE report 10080777 ↗

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