BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIRE, SURGICAL

    MDR report key: 3813764 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11459
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 21, 2014
    Manufacturer
    DEPUY SYNTHES (USA)
    Product Code
    LRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED: NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE.APIVATTHAKAKUL, T., PHORNPHUTKUL, C., BUNMAPRASERT, T., SANANPANICH, K., AND DELL¿OCA, A. (2012). PERCUTANEOUS CERCLAGE WIRING AND MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO): A PERCUTANEOUS REDUCTION TECHNIQUE IN THE TREATMENT OF VANCOUVER TYPE B1 PERIPROSTHETIC FEMORAL SHAFT FRACTURES. ARCH ORTHOP TRAUMA SURG, 132, 813-822. THERE WERE NINE CASES THAT WERE FOLLOWED-UP FOR AT LEAST 12 MONTHS POST-OPERATIVELY. THE AVERAGE FOLLOW-UP TIME WAS 13.2 MONTHS (RANGE 12¿18 MONTHS). IMPLANTS USED FOR FIXATION OF THE FRACTURES INCLUDED ONE LOCKING COMPRESSION PLATE (LCP) DISTAL FEMUR AND EIGHT CURVED BROAD 4.5 LOCKING PLATES (SYNTHES). THE FRACTURE PATTERN WAS SPIRAL IN FOUR PATIENTS, OBLIQUE IN THREE PATIENTS, AND WEDGED IN TWO PATIENTS. THE AVERAGE REDUCTION TIME, AS DEFINED IN MATERIALS AND METHODS WAS 24.4 MINUTES (RANGE 7¿45 MINUTES). CLOSED REDUCTION WAS SUCCESSFUL IN ALL BUT ONE CASE. THE AVERAGE FIXATION TIME WAS 79 MINUTES (RANGE 53¿100 MINUTES). DIFFICULTY CONTOURING THE PLATE RESULTED IN A FIXATION TIME OF 100 MINUTES IN ONE PATIENT AND WAS A RESULT OF A PREVIOUS REVISION HIP PROSTHESIS WITH STRUT GRAFT AND WIRING (CASE ONE). THE AVERAGE OPERATIVE TIME WAS 103 MINUTES (RANGE 75¿140 MINUTES). INTRAOPERATIVE CONTOURING OF THE LCP DISTAL FEMUR WAS NEEDED TWO TIMES TO MATCH THE ANATOMY OF THE PROXIMAL FEMUR. BLOOD LOSS WAS LESS THAN 100 CUBIC CENTIMETRE AND ONLY TWO PATIENTS NEEDED BLOOD TRANSFUSIONS POST-OPERATIVELY. ALL FRACTURES HEALED WITH A MEAN TIME TO UNION OF 18 WEEKS (RANGE 16¿20 WEEKS). THERE WAS ONE IMPLANT WHICH BENT POST-OPERATIVELY BY TEN DEGREES. THIS DID NOT PROGRESS AND THE FRACTURE WENT ON TO HEAL UNEVENTFULLY IN 16 WEEKS. NO SCREW BREAKAGE, IMPLANT LOOSENING OR FAILURE WAS OBSERVED. SEVEN PATIENTS RETURNED TO THEIR PREVIOUS LEVEL OF MOBILITY. ONE PATIENT DEVELOPED PAIN AROUND THE KNEE FROM OSTEOARTHROSIS AND REMAINED DEPENDENT ON A WALKER. ONE PATIENT REMAINED MOBILE WITH A WALKER DUE TO HEMIPARESIS FROM STROKE. THERE WERE NO VASCULAR OR NERVE INJURIES, NO WOUND COMPLICATIONS OR INFECTIONS. ONE PATIENT HAD MINIMAL PAIN IN THE MID-THIGH FROM PROMINENCE OF THE WIRE TIP. THIS REPORT IS FOR AN UNKNOWN SYNTHES WIRE. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291075 WIRE, SURGICAL LRN DEPUY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention