VA-LCP 02.124.412Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982042859), received between Dec 12, 2016 and Jun 11, 2025 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025 THE THREADS ON BOLT (03.231.005) WERE STRUGGLING TO ENGAGE WITH PLATES PROPERLY. PRESUMABLY DUE TO WEAR OVER YEARS OF USE. WHILE TRYING TO ATTACH BOLT TO DISTAL FEMUR PLATE (02.124.412) THE FIT WASN¿T SECURE AND DAMAGED THE THREADS IN THE PLATE. THE PLATE COULD NO LONGER BE USED WITH AN AIMING ARM, SO ANOTHER TRAY NEEDED TO BE OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184048 ↗
• InjuryNov 1, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  THE BELOW COMPLAINTS ARE LINKED. THIS COMPLAINT WILL BE CAPTURED UNDER 2 SEPARATE COMPLAINTS AS LISTED BELOW: (B)(4).

  Patient problems: Arthritis; Bone Fracture(s); Fall; Nerve Damage; Pain

  MAUDE report 18047152 ↗
• MalfunctionFeb 2, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE ALLEGED IMPLANTS WERE STRIPPED WHEN TRYING TO ATTACH THE AIMING ARM. THE HANDLES FOR THE MULTI WIRE GUIDE DID NOT FULLY CONNECT TO THE MULTIPLE WIRE GUIDE AND PARALLEL GUIDE, GETTING STUCK BEFORE FULLY CONNECTING, DAMAGING THE GUIDES. MULTIPLE SETS WERE OPENED TO SEE IF IT THERE WAS A SOLUTION, THE STANDARD GUIDE FROM THE 6.5/7.3 CANNULATED SET WAS ULTIMATELY USED. A TNA WAS PERFORMED AND THE DRILL BIT HIT THE NAIL AFTER USING THE COMPRESSION FEATURE, DEPTH GAUGE WAS BENT FROM USAGE AND FADED. THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287257 ↗
• InjuryApr 14, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DISTAL FEMUR OPEN REDUCTION INTERNAL FIXATION REVISION OCCURRED ON (B)(6) 2022 DUE TO MULTIPLE 5.0MM VA LOCKING SCREWS BACKING OUT OF PLATE. IT IS UNKNOWN WHEN THE ORIGINAL SURGERY OCCURRED. DURING THE REVISION THE SURGEON ATTEMPTED TO RE-TIGHTEN THE SAME SCREW BACK INTO THE PLATE WITH A SCREWDRIVER AND APPROPRIATE 6NM TOQUE LIMITING T HANDLE. THE RE-TIGHTENING OF THE SCREWS DID NOT WORK AS THE SCREW HEADS WERE NOT LOCKING INTO THE PLATE. UPON REMOVAL AND INSPECTION OF THE ORIGINAL 12H VARIABLE ANGLE CURVED CONDYLAR PLATE, IT WAS NOTED BY SURGEON THAT THE SCREW HOLES OF THE PLATE AND THE LOCKING THREADS ON THE 5.0MM VARIABLE ANGLE LOCKING SCREWS WERE COMPROMISED. HE HAD TO PLACE A NEW PLATE AND SCREWS IN THE PATIENT AS A CORRECTION FOR THE ORIGINAL SURGERY. NO SURGERY DELAYED AND THE PROCEDURE SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 6 FOR (B)(4). THIS REPORT IS FOR A CONDYLAR PLATE.

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

  MAUDE report 14110920 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER THE SURGERY DURING THE REMOVAL OF VALCP CURVED CONDYLAR PLATE, SCREWS, AND A ZIMMER RETROGRADE NAIL DUE TO INFECTION AND NONUNION. PATIENT¿S PREVIOUS BELOW KNEE AMPUTATION WAS REVISED TO AN ABOVE KNEE AMPUTATION. THE PATIENT EXPERIENCED NO POST-OP DEVICE MALFUNCTION. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES.

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

  MAUDE report 13839732 ↗
• InjurySep 2, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THERE WAS A REMOVAL OF A BROKEN 4.5MM VARIABLE ANGLE LCP CURVED CONDYLAR PLATE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A 4.5MM VARIABLE ANGLE LCP CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 12415382 ↗
• InjuryJan 17, 2020Break; Break

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF A BROKEN VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE OF A DISTAL FEMUR. THE ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2019. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Code Available

  MAUDE report 9604398 ↗
• InjuryOct 9, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) CURVED CONDYLAR PLATE ON (B)(6) 2019. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH THE VA LCP CURVED CONDYLAR PLATE AND LOCKING SCREWS FOR A RIGHT DISTAL FEMUR FRACTURE IN (B)(6) 2019. ON AN UNKNOWN DATE AFTER THE SURGERY, THE PATIENT FELT A POP WHILE WALKING AND EXPERIENCED PAIN AND DIFFICULTY IN WALKING. THE PATIENT THEN WENT TO THE HOSPITAL AND DISCOVERED THAT THE PLATE BROKE, BUT THE SCREWS WERE INTACT. THE SURGEON WAS GOING TO REMOVE THE BROKEN PLATE AND REPLACE WITH ANOTHER PLATE BUT WHEN THE AFFECTED AREA WAS OPENED, AN INFECTION WAS NOTED. THE SURGEON PLACED ANTIBIOTIC CEMENT BEADS AROUND THE FRACTURE AND PERFORMED A SPANNING EXFIX TO HOLD THE FRACTURE AT LENGTH FOR STABILITY UNTIL THE INFECTION RESIDES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. ALL THE IMPLANTS WERE SUCCESSFULLY EXPLANTED. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) 4.5 MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT. THIS IS REPORT IS 1 OF 9 FOR (B)(4).

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

  MAUDE report 9173276 ↗
• InjuryJun 28, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT DISTAL FEMUR DUE TO A BROKEN VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE AND NON-UNION. THE PATIENT ORIGINALLY HAD AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE RIGHT DISTAL FEMUR ON DECEMBER 28, 2018. AT THE TIME OF THE FIRST SURGERY THE PATIENT WAS IMPLANTED WITH A 4.5 VA-LCP CURVED CONDYLAR PLATE 12 HOLE RIGHT PLATE AND THREE (3) 4.5 CORTEX SCREWS AND TEN (10) 5.0 LOCKING SCREWS. DURING THE REVISION, THE SURGEON REMOVED THE BROKEN PLATE, THE SCREWS AND REPLACED WITH A RETROGRADE NAIL TO STABILIZE THE FRACTURE. ALL HARDWARE WERE REMOVED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 4.5 CORTEX SCREW SELF-TAPPING 70MM (PART #:214.870, LOT#: UNKNOWN, QUANTITY #:1). 4.5 CORTEX SCREW SELF-TAPPING 66MM (PART #:214.866, LOT#: UNKNOWN, QUANTITY #:1). 4.5MM CORTEX SCREW SELF-TAPPING 36MM (PART #:214.836, LOT#: UNKNOWN, QUANTITY #:1). 5.0MM VA LOCKING SCREW/STRDRV/SELF TAPPING 70MM (PART #: 02.231.270, LOT#: 2L35743, QUANTITY #:1). 5.0 VA LOCKING SCREW/STRDRV/SELF TAP

  Patient problems: No Code Available

  MAUDE report 8746174 ↗
• InjuryMar 19, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF PLATE AND SCREWS ON (B)(6) 2019, DUE TO BROKEN VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR RIGHT SIDE AT THE 6TH AND 7TH HOLE OF THE SHAFT OF THE PLATE. THE PATIENT HAS AN ORIGINAL IMPLANT OF NINE (9) UNKNOWN LOCKING SCREWS AND TWO (2) UNKNOWN CORTEX SCREWS ON (B)(6) 2019. THE PATIENT HAD BEEN WALKING ON IT AGAINST THE SURGEONS DIRECTION, AND A PARTIAL WEIGHT BEARING PLATE BROKE. ALL THE IMPLANTS WERE REMOVED SUCCESSFULLY AND THE PATIENT WAS REPAIRED WITH INTRAMEDULLARY RETROGRADE ANTEGRADE FEMORAL NAIL SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 9). UNK - SCREWS: CORTEX (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 2). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8432897 ↗
• InjuryMar 11, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019 A REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN VARIABLE ANGLE LOCKING COMPRESSION PLATE AND FIX THE FRACTURE WITH A NEW PLATE. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8408378 ↗
• InjuryFeb 11, 2019Break; Break

  CONCOMITANT DEVICES: 5.0MM VARIABLE ANGLE LOCKING SCREW (PART: 02.221.2XX , LOT: UNKNOWN, QUANTITY: 10), 4.5MM CORTEX SCREWS (PART: 214.8XX , LOT: UNKNOWN, QUANTITY: 3).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8325209 ↗
• InjuryJan 4, 2019Break; Break

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) CURVED CONDYLAR PLATE, A VA DISTAL FEMUR PLATE, AND AN UNKNOWN QUANTITY OF SCREWS ON UNKNOWN DATE. ON ANOTHER UNKNOWN DATE POST-OPERATIVELY, PATIENT PRESENTED WITH PAIN. X-RAYS TAKEN ON UNKNOWN DATE REVEALED DELAYED UNION AND A BROKEN VA LCP CONDYLAR PLATE. PATIENT WAS RETURNED TO SURGERY ON AN UNKNOWN DATE WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS REVISED TO A HINGED TOTAL KNEE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. CONCOMITANT DEVICES: VA DISTAL FEMUR PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.5MM VA LCP CURVED CONDYLAR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 8217081 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) DISTAL FEMUR PLATE AND UNKNOWN SCREW FROM THE PATIENT¿S DISTAL FEMUR DUE TO NON-UNION. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. THE PATIENT WAS REVISED TO A 4.5MM LCP CONDYLAR PLATE AND UNKNOWN SCREWS. ON (B)(6) 2018, THE PATIENT UNDERWENT A SECOND REVISION PROCEDURE TO REMOVE THE 4.5MM LCP CONDYLAR PLATE AND UNKNOWN SCREWS FROM THE PATIENT¿S DISTAL FEMUR DUE TO NON-UNION. THE PATIENT WAS REVISED TO A PROSTHETIC DISTAL FEMUR. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR A 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT WILL ADDRESS THE VA LCP DISTAL FEMUR PLATE AND UNKNOWN SCREWS REMOVED ON (B)(6) 2017. THE REVISION SURGERY ON (B)(6) 2018 HAS BEEN CAPTURED UNDER COMPLAINT NUMBER (B)(4).

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

  MAUDE report 7793376 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR USING SYNTHES VA CONDYLAR PLATE AND SCREWS. THE OUTCOME OF THE SURGERY WAS A NONUNION. ON (B)(6) 2018 THE SURGEON PERFORMED A REVISION ORIF OF THE DISTAL FEMUR TO ADDRESS THE NONUNION. THE PLATES AND SCREWS WERE INTACT AND SUCCESSFULLY REMOVED. A BONE GRAFT WAS INSERTED AND A NEW SYNTHES VA CONDYLAR PLATE AND SCREWS WERE INSERTED IN THE PATIENT. THE REVISION WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 8 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7406611 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION ON (B)(6) 2018 DUE TO A NONUNION OF THE RIGHT DISTAL FEMUR. INITIALLY, ON (B)(6) 2016, PATIENT WAS IMPLANTED WITH ONE (1) 4.5MM VARIABLE ANGLE ¿ LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT, FOUR (4) 4.5MM CORTEX SCREWS, THREE (3) 5.0 MM LOCKING SCREWS, AND SIX (6) 5.0 MM CANNULATED SCREWS. ALL HARDWARE WAS REMOVED AND PATIENT WAS REVISED TO AN INTERMEDULLARY 13.0 MM BY 360.0 MM CANNULATED FEMORAL NAIL. HARDWARE REMOVAL AND REVISION WERE COMPLETED SUCCESSFULLY WITH NO COMPLICATION. PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 4.5MM VA LCP CURVED CONDYLAR PLATE. (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7265300 ↗
• InjuryDec 20, 2017Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4) , A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION AND ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION CURVED CONDYLAR PLATE WITH 12 HOLES (266MM, RIGHT) IN (B)(6) 2017. AN EXPLANT PROCEDURE WAS PERFORMED IN (B)(6) 2017. CONCOMITANT DEVICE REPORTED: SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 7134125 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A DISTAL FEMUR FRACTURE ON (B)(6) 2017 AFTER A FALL. THE PATIENT WAS IMPLANTED WITH A 4.5 MM LOCKING COMPRESSION PLATE VARIABLE ANGLE (LCP VA) CONDYLAR PLATE SYSTEM. POST-OPERATIVELY AN X-RAY TAKEN ON UNKNOWN DATE REVEALED NONUNION. ON (B)(6) 2017, THE PATIENT WENT BACK FOR REVISION SURGERY AND ANOTHER LCP CONDYLAR VA PLATE WAS PLACED WITH 10 CC OF NORIAN. ALL HARDWARE WAS INTACT AND EASILY REMOVED WITH NO DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS STABLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7074649 ↗
• InjuryNov 6, 2017Break; Break

  IT WAS REPORTED THAT THE SECURITY STAFF AT THE FACILITY FOUND A BROKEN 4.5MM VARIABLE ANGLE-LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE AND NOTIFIED THE STERILE PROCESSING COORDINATOR OF THEIR FINDING. NO INFORMATION IS AVAILABLE ON THE PATIENT WHO RECEIVED THE DEVICE, WHEN IT WAS IMPLANTED, OR WHEN IT WAS EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Information

  MAUDE report 7004871 ↗
• InjuryMay 26, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT, WHO UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF THE DISTAL RIGHT FEMUR ON (B)(6) 2016, HAD A REVISION SURGERY ON (B)(6) 2017, AFTER THE PLATE WAS NOTED TO BE BROKEN AND THE PATIENT SUFFERED A NON-UNION. ON AN UNKNOWN DATE THE POST-OPERATIVE NON-UNION AND BROKEN PLATE WAS NOTED. THE PLATE, BROKEN AT A SCREW HOLE (FOURTH COMBI HOLE FROM THE BOTTOM) AND TWELVE (12) INTACT SCREWS WERE ALL EASILY REMOVED. IT IS UNKNOWN IF THE PATIENT HAD A COMPLAINT OF PAIN. THE PATIENT WAS REVISED WITH AN ANTEGRADE/RETROGRADE FEMORAL NAIL, ONE SPIRAL BLADE AND FOUR, 5.0 MM LOCKING SCREWS. THE SURGEON ALSO USED THE REAMER IRRIGATOR ASPIRATOR SYSTEM TO HARVEST BONE GRAFT FROM BOTH FEMURS. THE BONE GRAFT MATERIAL WAS IMPLANTED IN CONJUNCTION WITH THE NAIL. STANDARD CULTURES WERE TAKEN AS A PRECAUTION, BUT THE SURGEON DID NOT SUSPECT AN INFECTION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAYS AND THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE. CONCOMITANT DEVICES REPORTED: SCREWS (QUANTITY 12). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Impaired Healing

  MAUDE report 6593772 ↗
• InjuryDec 12, 2016Break; Break

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) CURVED CONDYLAR PLATE APPROXIMATELY 4 MONTHS AGO. ON AN UNKNOWN DATE, IT WAS IDENTIFIED THAT THE PLATE HAD BROKEN. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2016 FOR REVISION SURGERY. THE BROKEN PLATE WAS REMOVED AND PATIENT WAS REPLATED. THERE WAS NO DELAY IN SURGERY OR FRAGMENTS NOTED. SURGERY WAS SUCCESSFUL AND PATIENT OUTCOME WAS GOOD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 6167135 ↗

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