VA-LCP 02.124.416Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982042934), received between Mar 28, 2018 and Aug 6, 2025 — classified as 20 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DISTAL FEMUR VA CONDYLA PLATE WAS BROKEN. THERE WAS POSSIBLE INFECTION. THE PLATE HAD TO REVISE WITH A NEW PLATE.

  Patient problems: Unspecified Infection

  MAUDE report 22726050 ↗
• InjuryMar 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025, THAT THE YELLOW STRIPED CONNECTING SCREW DID NOT THREAD TIGHTLY ONTO THE VA CONDYLAR PLATE. THE SCREW MUST BE STRIPPED. IT STRIPPED THE LOCKING HOLE ON THE RIGHT 16 HOLE CURVED VA CONDYLAR PLATE. IT WON'T THREAD INTO ANY PLATE. SURGEON WANTED EVERYTHING EXCHANGED. ACTION TAKEN INCLUDE TAKING THE AIMING ARM OFF AND CUTTING THE LEG OPEN TO SEE THE PLATE. IT¿S THE 2ND TIME THE BOLT CAME OFF THE PLATE. THERE WERE A SURGICAL DELAY OF 45 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698106 ↗
• MalfunctionMar 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A PROCEDURE THERE WAS A INTER-PROSTHETIC FRACTURE WITH A DISTAL FEMUR FRACTURE. A FRN WAS INSERTED AND THEN TWO PLATES WERE INSERTED DISTALLY. A LATERAL PLATE WAS INSERTED AND THE SAME PLATE, BUT CONTRALATERAL SIDE WAS PUT ON THE MEDIAL SIDE. DURING THE FRN, THE PROXIMAL PORTION BECAME SNAGGED UP. THE DRIVE CAP BROKE DURING MALLEATING. WHILE INSERTING BOTH PLATES DISTALLY, THE CENTER HOLE DID NOT LOCK INTO THE PLATE. UNSURE IF IT WAS DUE TO THE TRAFFIC OF THE SCREWS, AND MAKING THE SCREWS SKIVE OFF AXIS. DEPTH GAUGE WAS ALSO BENT IN THE PROCESS OF MEASURING FOR SCREWS. THERE WERE FOUR (4) MINUTES OF SURGICAL DELAY. THIS COMPLAINT INVOLVES FIVE (5) DEVICE. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CURVED COND PL/16 HOLE/336/RT THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16649229 ↗
• InjuryNov 16, 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 REVISION FIXATION DUE TO A PERI PROSTHETIC FRACTURE. THERE WAS REMOVAL OF AN UNKNOWN NUMBER OF LOCKING AND CORTICAL SCREWS AND PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 15804657 ↗
• InjuryApr 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS SEATED AND UPON STANDING UP, PATIENT HEARD A LOUD SOUND AND COMPLAINED OF PAIN ON HER RIGHT FEMUR. PATIENT WAS BROUGHT TO CLINIC FOR CONSULTATION. DOCTOR ASKED HER TO TCA NEXT WEDNESDAY ON (B)(6) 2022 FOR NEXT PLAN OF ACTION. PATIENT DID HER SURGERY IN (B)(6) 2020. THIS COMPLAINT INVOLVES ONE (1) DEVICE 4.5 VA-LCP CURVED COND PL/16 HOLE/336/RT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 14160709 ↗
• InjuryAug 11, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT DESCRIPTION: ON (B)(6) 2019 A CLINIC REPORTED THAT PATIENT HAD A RECENT FALL, AND SUSTAINED A DISPLACED FRACTURE DISTAL TIP. PAIN LEVEL IS 4/10. ON (B)(6) 2019, PROGRESS NOTE REPORTED THAT A FRACTURE PLATE AT THE SITE OF PREVIOUS FRACTURE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12307572 ↗
• InjuryJun 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A ORIF DISTAL FEMUR PROCEDURE. IT WAS NOTED THAT THE PLATE BROKE AT HOLE NUMBER 8 AND ALSO THE 3 - 4.5MM CORTICAL SCREWS BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THE PROCEDURE IS COMPLETED. NO PATIENT CONSEQUENCES NOTED. THIS COMPLAINT INVOLVES 10 DEVICES. THIS REPORT IS FOR 1 4.5 VA-LCP CURVED COND PL/16 HOLE/336/RT. THIS REPORT IS 1 OF 10 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12063843 ↗
• MalfunctionMar 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021 THE AIMING ARM WAS PLACED ON THE CONDYLAR PLATE AND STRIPPED THE HOLE. THE ARM WOULD NOT STAY ATTACHED. NO FURTHER INFORMATION PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11487176 ↗
• InjuryNov 16, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON TRIED TO LOAD THE UNKNOWN AIMING ARM, THE VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE WHERE THE HOLE WAS ASSOCIATED WITH THE ATTACHING POST AND THE UNKNOWN THREADED GUIDE WOULD NOT THREAD TO THE PLATE. SO THE SURGEON EXAMINED THE HOLE AND LOOKS LIKE THE THREAD ON THE HOLE MAY BE FLATTENED OUT SO THE SURGEON CHOSE A SHORTER UNKNOWN PLATE WHICH WAS COMPLETELY SUFFICIENT. THE SURGEON COMMENTED THAT HE WAS VERY HAPPY WITH THE RESULT OF THE 14 HOLE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 2 MINUTES. CONCOMITANT DEVICES REPORTED: UNKNOWN AIMING ARM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN LOCKING. NEUTRAL GUIDE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN INSERTION HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES 1 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10844382 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT INFORMATION: IT WAS REPORTED THAT THE PLATE AND SCREWS WERE SUCCESSFULLY REMOVED. THE PATIENT HAD FELL AND RE FRACTURED LEADING TO PERFORM A KNEE REVISION.

  Patient problems: Injury

  MAUDE report 10314545 ↗
• MalfunctionMay 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A PROCEDURE THE LOCKING HOLE OF A 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT WAS STRIPPED, WHICH WOULD NOT ALLOW THE AIMING ARM TO BE ATTACHED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE IS NO KNOWN PATIENT CONSEQUENCE. PATIENT¿S OUTCOME IS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR 1 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10063448 ↗
• InjuryMay 12, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4.5 VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) HANDLE BROKE AT MID SHAFT, POST-OP. THE DEVICE WAS IMPLANTED ON (B)(6) 2019. ON (B)(6) 2020 THE VARIABLE ANGLE LOCKING COMPRESSION PLATE WAS REPLACED AND A RETROGRADE FEMORAL NAIL WAS USED BECAUSE THE BONE DID NOT HEAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BROKEN FRAGMENTS WERE REMOVED EASILY. THE PATIENT WAS REPORTED AS STABLE AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN) THIS REPORT INVOLVES 1 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 10048027 ↗
• InjuryMay 4, 2020Break; Break

  IT WAS REPORTED THAT ON AN (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE THAT WAS BROKEN. THE PLATE WAS COMPLETELY REMOVED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Code Available

  MAUDE report 10022314 ↗
• InjuryJan 23, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION FEMUR, REMOVAL OF DEEP HARDWARE AND REVISION ORIF OF RIGHT DISTAL FEMUR DUE TO A LATERAL HARDWARE FRACTURE AND FAILURE OF THE PLATE JUST ABOVE THE CONDYLES IN THE RIGHT LOWER EXTREMITY WHERE A POP WAS HEARD. ON (B)(6) 2018, THE PATIENT PRESENTED WITH RIGHT DISTAL FEMORAL SUPRACONDYLAR PROSTHETIC FRACTURE ABOVE A WELL-FIXED TOTAL KNEE REPLACEMENT AND UNDERWENT AN ORIF OF RIGHT DISTAL FEMORAL PERIPROSTHETIC FRACTURE DUE TO MECHANICAL FALL WHICH WAS REVEALED THROUGH X-RAYS. THE PATIENT HAS A HISTORY OF BILATERAL TOTAL SHOULDER REPLACEMENTS, BILATERAL TOTAL KNEE REPLACEMENTS, AND BILATERAL TOTAL HIP REPLACEMENTS. THE PATIENT WAS IMPLANTED WITH A DEPUY SYNTHES DISTAL FEMORAL VARY ANGLE LOCKING PLATE. IN (B)(6) 2018 THE PATIENT IS STILL HAVING PAIN MOSTLY IN THE MEDIAL ASPECT OF THE JOINT POINTING ALONG THE MEDIAL HAMSTRINGS AND MEDIAL FEMORAL CONDYLE. THERE IS NO CREPITANCE BUT THERE IS STIFFNESS. X-RAY REVEALED A WELL ALIGNED HARDWARE . FRACTURE CONSOLIDATION AROUND THE DISTAL FEMUR AT THE AREA OF PRIOR TRANSVERSE FRACTURE SITE. THERE REMAINS MEDIAL SCREW WITH ABUNDANT CALLOUS FORMATION OVER

  Patient problems: No Code Available; Pain

  MAUDE report 9623332 ↗
• MalfunctionJan 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE WAS DISCOVERED CROSS-THREADED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9622511 ↗
• InjuryNov 13, 2019Crack; Material Deformation; Crack; Material Deformation

  CONCOMITANT DEVICES: VA LOCKING SCREW L75MM (PART #: 02.231.275, LOT #: 4L36645, QUANTITY: 2), VA LOCKING SCREW L75MM (PART #: 02.231.275, LOT #: 4L97581, QUANTITY: 1), VA LOCKING SCREW L70MM (PART #: 02.231.270, LOT #: 2L86783, QUANTITY: 1), VA LOCKING SCREW L70MM (PART #: 02.231.270, LOT #: 4L84078, QUANTITY: 1), VA LOCKING SCREW L60MM (PART #: 02.231.260, LOT #: 2522949, QUANTITY: 1), VA LOCKING SCREW L38MM (PART #: 02.231.238, LOT #: 4L72601, QUANTITY: 1), VA LOCKING SCREW L38MM (PART #: 02.231.238, LOT #: 4L92506, QUANTITY: 1), VA LOCKING SCREW L34MM (PART #: 02.231.234, LOT #: UNK, QUANTITY: 1), VA LOCKING SCREW L16MM (PART #: 02.231.016, LOT #: L773486, QUANTITY: 1) AND UNKNOWN SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1).

  Patient problems: No Code Available

  MAUDE report 9316833 ↗
• InjuryApr 19, 2019Break; Break

  5/13/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF VARIABLE ANGLE (VA) CURVED CONDYLAR PLATE THAT BROKE AFTER BEING IMPLANTED IN THE PATIENT 3 MONTHS PRIOR. THE PATIENT'S LEG WAS NOT STRAIGHT AND PATIENT CANNOT WALK. ORIGINALLY, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF PERIPROSTHETIC FEMUR FRACTURE ON AN UNKNOWN DATE. THE PATIENT RECEIVED A FEMORAL NAIL TO FIX THE FEMUR WHICH DISPLACED AFTER THE PLATE BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8531491 ↗
• InjuryJun 5, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY ON OPEN REDUCTION INTERNAL FIXATION (ORIF) ON RIGHT FEMUR PERIPROSTHETIC FRACTURE DUE TO NONUNION/DELAYED HEALING AND POSSIBLE BROKEN PLATE ON (B)(6) 2018. DURING THE PROCEDURE, THE 16-HOLE 4.5 VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE ON THE LATERAL SIDE WAS CONFIRMED FOR REMOVAL. ON THE MEDIAL SIDE WAS A 4.5 NARROW LOCKING COMPRESSION PLATE AROUND 12-HOLES LONG. SURGEON REMOVED ALL HARDWARE AND REPLACED THE LATERAL SIDE WITH A NEW 4.5 VA-LCP CURVED CONDYLAR PLATE AND AN ANTERIOR BROAD 4.5 LCP PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; THE PATIENT OUTCOME WAS NOT REPORTED. CONCOMITANT DEVICES REPORTED: 4.5 NARROW LOCKING COMPRESSION PLATE (PART 214.621, LOT UNKNOWN, QUANTITY 1); SCREWS (PART/LOT UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7568818 ↗
• InjuryApr 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A MASQUELET PROCEDURE ON (B)(6) 2017 SINCE THE PATIENT WAS MISSING A LARGE AMOUNT OF BONE. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017 BY OPEN REDUCTION INTERNAL FIXATION PROCEDURE FOR TREATMENT OF A GRADE 3 OPEN FEMUR FRACTURE. THE HARDWARE WAS IMPLANTED ON (B)(6) 2017 DURING THE INITIAL SURGERY AND INCLUDED THE FOLLOWING HARDWARE (ONE 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT, FOUR 5.0MM CANNULATED LOCKING SCREWS, ONE 5MM LOCKING SCREWS, FOUR 4.5MM CORTEX SCREWS, TWO 3.5MM CORTEX SCREWS, 3.0MM HEADLESS SCREW AND 1-3.0MM HEADLESS SCREW.) ALL THE IMPLANTED HARDWARE WAS REMOVED INTACT DURING REVISION SURGERY ON (B)(6) 2018 DUE TO INFECTION AND DELAYED HEALING, EXCEPT FOR ONE 1-3.0 HEADLESS SCREW WHICH NOT ABLE TO BE REMOVED AND WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY AND THE PATIENT WAS OK AFTER THE SURGERY. THIS COMPLAINT, (B)(4), CAPTURED THE EVENT OF THE MASQUELET PROCEDURE. (B)(4), SOURCE COMPLAINT, CAPTURED THE HARDWARE REMOVAL DUE TO INFECTION AND DELAYED HEALING. (B)(4) CAPTURED THE SCREW THAT WAS NOT REMOVED DURING REVISION SURGERY. THIS COMPLAINT INVOLVES SEVEN (7)

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7452071 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A REVISION SURGERY ON (B)(6) 2018 FOR REMOVAL OF HARDWARE DUE TO INFECTION AND DELAYED HEALING. THE HARDWARE WAS IMPLANTED (ONE 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT, FOUR 5.0MM CANNULATED LOCKING SCREWS, ONE 5MM LOCKING SCREWS, FOUR 4.5MM CORTEX SCREWS, TWO 3.5MM CORTEX SCREWS, 3.0MM HEADLESS SCREW AND 1-3.0MM HEADLESS SCREW) ON (B)(6) 2017 BY OPEN REDUCTION INTERNAL FIXATION PROCEDURE FOR TREATMENT OF A GRADE 3 OPEN FEMUR FRACTURE. AFTER THE IMPLANTATION OF HARDWARE ON (B)(6) 2017, THE PATIENT UNDERWENT A MASQUELET PROCEDURE ON (B)(6) 2017 AS THE PATIENT WAS MISSING A LARGE AMOUNT OF BONE, WHICH IS CAPTURED UNDER (B)(4). AFTER ALL THESE THE PATIENT SUFFERED FROM INFECTION AND DELAYED HEALING SO THE HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2018. ALL THE IMPLANTED HARDWARE WAS REMOVED INTACT, EXCEPT FOR ONE 1-3.0 HEADLESS SCREW WHICH NOT ABLE TO BE REMOVED AND WAS LEFT INSIDE THE PATIENT AND WAS CAPTURED IN (B)(4). AFTER THE REMOVAL OF HARDWARE BOTH STIMULANT BEADS AND ANTIBIOTIC SPACER WERE PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY AND THE PATIENT WAS OK AFTER THE SURGERY. THIS CO

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7446740 ↗
• InjuryApr 17, 2018Bent; Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION OF ONE (1) 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE, SIX (6) LOCKING SCREWS AND TWO (2) NON-LOCKING SCREWS ON (B)(6) 2018 DUE TO A BENT PLATE. THE ENTIRE CONSTRUCT REVISED WAS IMPLANTED ON AN UNKNOWN DATE. SUBSEQUENTLY, DUE TO THE PATIENT BEING NON-COMPLIANT, THE PLATE BENT BUT DID NOT BREAK. SURGEON REVISED THE PATIENT TO AN UNKNOWN PLATE AND SCREWS CONSTRUCT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT CONDITION AFTER THE SURGERY IS UNKNOWN. CONCOMITANT DEVICES REPORTED: LOCKING SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 6); NON-LOCKING SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7438465 ↗
• InjuryApr 11, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION OF THE DISTAL FEMUR USING A VARIABLE ANGLE PLATE IN (B)(6) 2017. THE PATIENT WENT ON TO DEVELOP A NON-UNION AND A BONE GRAFT WAS PERFORMED IN (B)(6) 2017. THE PATIENT PRESENTED TO THE HOSPITAL EMERGENCY ROOM WITH A FAILED UNION AND A BROKEN PLATE ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2018, WHEN THE BROKEN PLATE WAS EASILY REMOVED AND THE PATIENT WAS IMPLANTED WITH A RETROGRADE STRYKER NAIL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY INTRAOPERATIVE EVENTS OR HARM TO THE PATIENT. THERE WERE NO SURGICAL DELAYS REPORTED. THE EXPLANTED PLATE WAS DISCARDED AND WILL NOT BE RETURNED FOR INVESTIGATION. CONCOMITANT DEVICES REPORTED UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR THE (B)(6) 2018, REVISION WHEN THE BROKEN PLATE WAS REMOVED AND THE PATIENT WAS IMPLANTED WITH A RETROGRADE STRYKER PLATE, (B)(4) IS FOR THE BONE GRAFT PERFORMED IN (B)(6) 2017 DUE TO A NON-UNION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7421642 ↗
• InjuryApr 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR USING A 4.5 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE IN (B)(6) 2017. THE PATIENT WENT ON TO DEVELOP A NON-UNION. A BONE GRAFT WAS PERFORMED IN (B)(6) 2017. THE PATIENT PRESENTED ON UNKNOWN DATE WITH A FAILED UNION AND A BROKEN PLATE. THE PATIENT WAS REVISED ON (B)(6) 2018, WHEN THE BROKEN PLATE WAS EASILY REMOVED AND THE PATIENT WAS IMPLANTED WITH A RETROGRADE COMPETITOR¿S NAIL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY INTRAOPERATIVE EVENTS OR HARM TO THE PATIENT. THERE WERE NO SURGICAL DELAYS REPORTED. THIS REPORT ADDRESSES THE BONE GRAFT PERFORMED IN (B)(6) 2017. THE REVISION DUE TO BROKEN HARDWARE IS ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 4.5 MM VA LCP CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7421619 ↗
• InjuryMar 28, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT (PROFESSIONAL MOTORCYCLE DRIVER) HAD ORIGINAL SURGERY SOMETIME IN LATE 1986 FOR TREATMENT OF A FEMUR FRACTURE DUE TO A MOTOR VEHICLE ACCIDENT (MVA). PATIENT WAS IMPLANTED WITH AN UNKNOWN SYNTHES NAIL AND AN UNKNOWN QUANTITY AND TYPE OF SCREWS. ON AN UNKNOWN DATE POST-OPERATIVELY, PATIENT HAD HEALED WELL AND THE NAIL CONSTRUCT WAS REMOVED WITH NO FURTHER ISSUES. ON (B)(6) 2014, PATIENT WAS STRUCK BY A MOTOR VEHICLE, RESULTING IN A FRACTURED FEMUR, TIBIA, AND FIBULA. THESE INJURIES REQUIRED MORE THAN NINETEEN (19) SURGERIES. ON (B)(6) 2014, THE FEMUR AND TIBIA FRACTURES WERE PLATED. IT IS REPORTED THAT ONE OF THE PLATES WAS THE 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE 16 HOLE 336MM-RIGHT. NO ISSUE WAS REPORTED. ON AN UNKNOWN DATE BETWEEN 2016 AND 2017, WHILE RIDING HIS MOTORCYCLE PATIENT WAS AGAIN INVOLVED IN A MOTOR VEHICLE ACCIDENT. THE PATIENT¿S FEMUR WAS AGAIN BROKEN. THE TWO (2) PLATES WERE ALSO BROKEN. ON UNKNOWN DATE, PATIENT WAS RETURNED TO SURGERY WHERE THE BROKEN PLATES AND SCREWS WERE REMOVED. PATIENT WAS REVISED TO A 95-DEGREE BLADE PLATE AND SCREWS TO ADDRESS THE NEW FEMUR FRACTURE. PATIENT IS CURRENTL

  Patient problems: Failure of Implant

  MAUDE report 7378172 ↗

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