VA-LCP 02.124.410Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982042811), received between Jan 13, 2017 and Apr 12, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Break” (8 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 16, 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.

• InjuryApr 12, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT RIGHT DISTAL FEMORAL RESECTION AND ENDOPROSTHETIC REPLACEMENT/REVISION DUE TO CHRONIC RIGHT DISTAL FEMUR PERIPROSTHETIC FRACTURE NONUNION AND FRACTURED LATERAL LOCKING PLATE. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16724931 ↗
• InjurySep 15, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A DISTAL FEMUR BROKEN PLATE. THE PLATE AND SCREW WERE REMOVED AND A NEW PLATE WAS IMPLANTED. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12475892 ↗
• InjuryJun 7, 2021Break; Break

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF RIGHT DISTAL FEMUR SYNTHES VA CONDYLAR PLATES FOR A RIGHT PERIPROSTHETIC DISTAL FEMUR FRACTURE. THE PLATE WAS BROKEN AND REMOVED. CONCOMITANT DEVICE REPORTED: 5.0MM PERIPROSTHETIC VA LCKNG SCREW/SLF-TPNG/STRDRV/10MM (PART # 02.231.010, LOT # UNKNOWN, QUANTITY# 1). 5.0MM PERIPROSTHETIC VA LCKNG SCREW/SLF-TPNG/STRDRV/12MM (PART # 02.231.012, LOT # UNKNOWN, QUANTITY# 1). 5.0MM PERIPROSTHETIC VA LCKNG SCREW/SLF-TPNG/STRDRV/14MM (PART # 02.231.014, LOT # UNKNOWN, QUANTITY# 1). 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/20MM (PART # 02.231.220, LOT # UNKNOWN, QUANTITY# 1). 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/30MM (PART # 02.231.230, LOT # UNKNOWN, QUANTITY# 1). 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/32MM (PART # 02.231.232, LOT # UNKNOWN, QUANTITY# 3). 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/38MM (PART # 02.231.238, LOT # UNKNOWN, QUANTITY# 1). 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/42MM (PART # 02.231.242, LOT # UNKNOWN, QUANTITY# 2) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/60MM (PART # 02.231.260, LOT # UNKNOWN, QUANTITY# 1). 5.0MM VARIABLE AN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11952755 ↗
• InjuryOct 30, 2019Break; Break

  IT WAS REPORTED THAT, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE DUE TO PLATE BREAKAGE. IT WAS REVISED INTO AN INTRAMEDULLARY NAIL. THE DATE OF THE ORIGINAL IMPLANT WAS (B)(6) 2019. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # /LOT # UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.5 MM VA-LCP CURVED CONDYLAR PLATE/ 10 HOLE/ 230 MM/ RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9256128 ↗
• InjuryJan 15, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON (B)(6) 2018. AN INTERLOCKING BOLT FOR VARIABLE-ANGLE LCP CONDYLAR INSERTION HANDLE AND AN UNKNOWN AIMING ARM WAS ATTACHED TO THE VARIABLE ANGLE-LCP CURVED CONDYLAR PLATE 10 HOLE. THE SURGEON USED AN INSERTION HANDLE TO SLIDE THE PLATE UP THE PATIENT'S LEG AND THE HANDLE THEN POPPED OFF. THE PLATE APPEARED TO BE STRIPPED WHERE THE LOCKING BOLT CONNECTS, AND AFTER SEVERAL ATTEMPTS TO REATTACH OR TIGHTEN IT DOWN, IT CONTINUED TO DISCONNECT. THE PLATE AND THE INTERLOCKING BOLT MALFUNCTIONED. THERE WAS NO ALLEGATION AGAINST THE AIMING ARM OR THE INSERTION HANDLE. INSTEAD, A 12-HOLE PLATE WAS USED INSTEAD OF THE 10-HOLE PLATE THAT MALFUNCTIONED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUALITY # 1) , UNKNOWN INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUALITY # 1). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8250022 ↗
• InjuryJan 11, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF THE VARIABLE ANGLE -LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE. IT WAS DISCOVERED AS BROKEN DUE TO UNKNOWN REASONS. THE SURGEON DECIDED TO PROCEED WITH A TOTAL KNEE REVISION. THE PLATE WAS BROKEN THROUGH THE NON-LOCKING PORTION OF THE FIFTH (5TH) HOLE IN THE SHAFT CLOSEST TO THE DISTAL END. THE PATIENT HAD AN IMPLANT OF PLATE AND UNKNOWN SCREWS ON AN UNKNOWN DATE. THE SCREWS AND PLATE FRAGMENTS WERE REMOVED SUCCESSFULLY AND EASILY WITHOUT ADDITIONAL INTERVENTION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PROCEDURE HAD NO ADVERSE EFFECT TO THE PATIENT. CONCOMITANT DEVICE: UNKNOWN SCREWS (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY, UNKNOWN). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8239535 ↗
• InjuryDec 6, 2018Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN UNKNOWN SURGERY. THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE WAS ATTACHED TO AN AIMING ARM. WHILE THE SURGEON WAS ATTEMPTING TO ATTACH PERCUTANEOUS TROCAR TO THE JIG, THE AIMING ARM FELL OFF THE PLATE. THIS OCCURRED A FEW TIMES DURING THE CASE UNTIL THE JIG WAS NO LONGER ABLE TO GRAB THE PLATE; PRESUMABLY THE HOLE IN THE PLATE WAS STRIPPED OUT. UPON PULLING THE PLATE, THE HEAD OF A CORTEX SCREW SELF-TAPPING BROKE OFF. THEY WERE ABLE TO RETRIEVE THE SCREW FRAGMENT IN THE MEDULLARY CANAL WITH SOME DIFFICULTY. A NEW, LONGER PLATE WAS PLACED AND NO OTHER PROBLEMS OCCURRED. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: TROCAR INSTRUMENT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), AIMING ARM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8139263 ↗
• InjuryJun 18, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY OF THE FEMUR PLATE AND UNKNOWN SCREWS DUE TO A NON-UNION OF A FEMUR FRACTURE RESULTING TO A BROKEN 4.5MM VARIABLE ANGLE-LOCKING COMPRESSION PLATE CURVED CONDYLAR PLATE RIGHT. THE PLATE AND SCREWS WERE REPLACED DURING THE PROCEDURE ON AN UNKNOWN DATE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A FEMORAL PLATE AND UNKNOWN SCREWS ON THE RIGHT FEMUR. ORIGINAL IMPLANT DATE WAS UNKNOWN. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: VARIABLE ANGLE LOCKING SCREWS (PART/LOT UNKNOWN, QUANTITY UNKNOWN); 4.5 CORTEX SCREWS (PART/LOT UNKNOWN QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7610671 ↗
• InjuryMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TWO 3.5MM ATTACHMENT PLATES ,FIVE 5.0MM LOCKING SCREWS, FOUR CABLES, ONE PLATE AND EIGHT 3.5MM LOCKING SCREWS ON (B)(6) 2018 DUE TO INFECTION. A PUS CAME OUT WHEN PATIENT WAS OPENED. A REMOVAL AND DEBRIDEMENT WERE PERFORMED. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2013. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY COMPLICATIONS AND WITHOUT ANY SURGICAL DELAY. PATIENT STATUS FOLLOWING THE PROCEDURE WAS REPORTED AS STABLE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7375060 ↗
• InjuryDec 1, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR AN ORIF (OPEN REDUCTION INTERNAL FIXATION) OF A DISTAL FEMUR. ON AN UNKNOWN DATE, THE PLATE WAS FOUND TO BE BROKEN, AND IT WAS DISCOVERED THAT THE PATIENT HAD DEVELOPED A NON-UNION, WHICH REPORTEDLY LED TO THE REMOVING OF THE BROKEN HARDWARE. ON (B)(6) 2017, THE PATIENT RETURNED TO THE OPERATING TO REMOVE BROKEN PLATE, FOUR (4) INTACT PROXIMAL SCREWS AND FIVE (5) INTACT DISTAL SCREWS. THE PATIENT WAS REVISED TO ANOTHER PLATE AND SCREW FIXATION WITH BONE GRAFT. THERE WAS NO REPORTED SURGICAL DELAY, NO FRAGMENTS LEFT IN THE PATIENT, NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETE, AND THE PATIENT WAS STABLE DURING AND FOLLOWING THE SURGERY. CONCOMITANT DEVICES: UNKNOWN 4.5 CORTEX SCREW SS (PART # UNKNOWN, LOT # UNKNOWN, QTY. 1); UNKNOWN 5.0 VARIABLE ANGLE LOCKING SCREWS SS (PART # UNKNOWN, LOT # UNKNOWN, QTY. 8). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 7077160 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ONE (1) PLATE AND TWELVE (12) SCREWS WERE REMOVED FROM A PATIENT¿S FEMUR AND SHE UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2017. THE INITIAL SURGERY WAS CONDUCTED ON (B)(6) 2016 TO TREAT A RIGHT DISTAL FEMUR FRACTURE AND ONE (1) PLATE AND TWELVE (12) SCREWS CONSTRUCT WAS IMPLANTED IN THE PATIENT. AS PER THE SURGEON, THE PATIENT HAD A VERY BADLY BROKEN DISTAL FEMUR INITIALLY AND HAD DEVELOPED POST-TRAUMATIC ARTHRITIS DUE TO THE SAME, THUS NEEDING A TOTAL KNEE REPLACEMENT. THE PLATE AND ALL SCREWS WERE REMOVED INTACT. THE PROCEDURE OF REMOVAL OF INITIAL IMPLANT CONSTRUCT AND TOTAL KNEE REPLACEMENT WAS CONDUCTED SUCCESSFULLY WITHOUT ANY COMPLICATIONS AND THERE WAS NO REPORTED SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE THIS IS REPORT 1 OF 13 FOR COMPLAINT (B)(4).

  Patient problems: Arthritis; No Code Available

  MAUDE report 7050407 ↗
• InjuryJan 13, 2017Break; Break

  IT WAS REPORTED THE PATIENT HAD A BROKEN PLATE AND A NON-UNION. THE PATIENT HAD A RIGHT INTRAMEDULLARY NAILING REVISION/HARDWARE REMOVAL SURGERY ON (B)(6) 2016. THE IMPLANT DATE WAS UNKNOWN. THE BROKEN PLATE WAS REMOVED WITH UNKNOWN LOCKING AND CORTICAL SCREWS WHICH WERE REMOVED INTACT. A LATERAL ENTRY FEMORAL NAIL AND THREE (3) SCREWS WERE IMPLANTED. THERE WAS NO SURGERY DELAY OR FRAGMENTS NOTED. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT OUTCOME WAS REPORTED AS GOOD. CONCOMITANT DEVICES REPORTED: LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Impaired Healing

  MAUDE report 6251029 ↗

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