BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION,BONE

    MDR report key: 4310561 · Received December 9, 2014

    Report

    Report Number
    2520274-2014-15171
    Event Type
    Injury
    Date Received
    December 9, 2014
    Report Date
    November 14, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. THE PFNA AUGMENTED IN REVISION SURGERY OF PROXIMAL FEMUR FRACTURES. SCOLA, A; GEBHARD, F; DEHNER, C; RODERER, G. THE OPEN ORTHOPAEDICS JOURNAL, 2014, 8, 232-236. THIS REPORT IS FOR AN UNKNOWN PFNA BLADE/UNKNOWN QUANTITY/UNKNOWN LOT. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE. THE PFNA AUGMENTED IN REVISION SURGERY OF PROXIMAL FEMUR FRACTURES. SCOLA, A; GEBHARD, F; DEHNER, C; RODERER, G. THE OPEN ORTHOPAEDICS JOURNAL, 2014, 8, 232-236. MODERN IMPLANTS FOR PROXIMAL FEMUR FRACTURE TREATMENT HAVE CLEARLY IMPROVED CLINICAL RESULTS. HOWEVER, COMPLICATIONS, INCLUDING CUT-OUT AND LOSS OF REDUCTION, REQUIRING REVISION SURGERY STILL OCCUR. A MAJOR CHALLENGE IN THESE CASES IS A LOSS OF BONE STOCK DUE TO THE EXISTING IMPLANT, WHICH IS USUALLY EXACERBATED BY OSTEOPOROSIS. A POTENTIAL SOLUTION IS THE AUGMENTATION OF IMPLANTS, FOR EXAMPLE, OF THE FEMORAL NECK BLADE USING BONE CEMENT. TEN PATIENTS WITH A MEAN AGE OF 76.5 YEARS WERE TREATED USING THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) (SYNTHES INC). THE PROXIMAL FEMORAL NAIL (PFN) AND PFNA WERE USED DURING THE INITIAL TREATMENT FOR ALL EXCEPT 2 WHO USED THE DYNAMIC HIP SCREW (DHS) AND COMPETITOR'S NAIL. IN FIVE CASES, REVISION SURGERY WAS PERFORMED BECAUSE OF A LOOSENING OF THE FEMORAL NECK IMPLANT, IN TWO CASES BECAUSE OF A PSEUDARTHROSIS, IN TWO CASES BECAUSE OF AN IMPLANT FAILURE AND IN ONE CASE BECAUSE OF A NEW FRACTURE WITH THE IMPLANT BEING IN SITU. THE INITIAL HARDWARE WAS REMOVED AND A PFNA AUGMENTED WAS IMPLANTED. THE PERFORATED FEMORAL NECK BLADE WAS AUGMENTED USING POLYMETHYL METHACRYLATE CEMENT. CLINICAL AND RADIOLOGICAL FOLLOW-UP WAS PERFORMED AT A MEAN OF 5.4 MONTHS. THE MAIN OUTCOME PARAMETERS WERE FRACTURE HEALING AND IMPLANT RELATED COMPLICATIONS. TECHNICAL HANDLING WAS UNEVENTFUL IN ALL CASES. NO CEMENT LEAKAGE INTO THE JOINT OCCURRED IN ANY OF THE CASES. THE MEAN AMOUNT OF CEMENT INJECTED WAS 5.3 ML. THE FRACTURE HEALED DURING FOLLOW-UP IN ALL CASES EXCEPT TWO PATIENTS WHO DIED FROM CAUSES UNRELATED TO THE PROCEDURE AND PRIOR TO COMPLETE CONSOLIDATION. PROBLEM-FREE ELECTIVE HARDWARE REMOVAL OF THE PFNA AUGMENTED WAS PERFORMED IN TWO CASES. THIS REPORT IS FOR PATIENT #6, 91YO FEMALE, UNK BLADE, RE-TRAUMA/NEAR CUT-OUT REQUIRING IMPLANT REMOVAL AND PFNA AUGMENTED, DIED 4 WEEKS LATER DUE TO HEART FAILURE. THIS REPORT IS FOR 11 OF 20 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PFNA BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795575 SCREW, FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention