BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5815176 · Received July 22, 2016

    Report

    Report Number
    2520274-2016-13543
    Event Type
    Injury
    Date Received
    July 22, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS DATE OF EVENT: SUBCAPITAL FEMORAL NECK FRACTURE AFTER HEALING OF AN INTERTROCHANTERIC FRACTURE STABILIZED BY A AO-PFN. SEIBERT. F, BOLDIN.G, SCHIPPINGER.G , AND SZYSZKOWITZ, (2001) EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY 11: 133-135 AUSTRIA. THIS REPORT IS FOR A UNKNOWN PROXIMAL FIXATION NAIL. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. INVESTIGATION COULD NOT BE 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

    LITERATURE ARTICLE RECEIVED:THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE. SUBCAPITAL FEMORAL NECK FRACTURE AFTER HEALING OF AN INTERTROCHANTERIC FRACTURE STABILIZED BY A AO-PFN. SEIBERT. F, BOLDIN.G, SCHIPPINGER.G , AND SZYSZKOWITZ, (2001) EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY 11: 133-135 AUSTRIA. THIS IS A CASE STUDY OF A (B)(6) FEMALE ORIGINALLY SUSTAINED A TROCHANTERIC FRACTURE FOLLOWING A FALL ON HER LEFT HIP. THE FRACTURE WAS TREATED WITH A PROXIMAL FEMUR NAIL (PFN), TWO MONTHS LATER THE FRACTURE SHOWED SOME COLLAPSE AND PROTRUSION OF THE GLIDING NECK SCREWS. TWELVE MONTHS LATER THE FRACTURE WAS CONSOLIDATED. THE HIP SCREWS WERE PROTRUDED 1.5 CM LATERALLY AND CAUSED IRRITATION OF THE OVERLYING SOFT TISSUES. THE SCREW WAS REMOVED. THE POSTOPERATIVE X-RAYS SHOWED A WELL UNITED INTROCHANTERIC FRACTURE. AT THREE WEEKS POST SCREW REMOVAL THE PATIENT PRESENTED WITH HIP AND KNEE PAIN WITH NO HISTORY OF A FALL. REPEAT X-RAYS SHOWED A SUBCAPITAL NECK FRACTURE WITH FEMORAL HEAD DISPLACEMENT. AN UNEVENTFUL TOTAL HIP REPLACEMENT WAS PERFORMED. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS IS FOR A UNKNOWN PROXIMAL FEMUR NAIL FIXATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470140 NAIL, FIXATION, BONE JDW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention