BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 5835464 · Received July 29, 2016

    Report

    Report Number
    2520274-2016-13735
    Event Type
    Injury
    Date Received
    July 29, 2016
    Report Date
    July 12, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: CHOY, WON-SIK, ET AL (2015) SURGICAL TREATMENT OF PATHOLOGICAL FRACTURES OCCURRING AT THE PROXIMAL FEMUR. YONSEI MED J 56(2):460-465, 2015. THIS REPORT IS FOR UNKNOWN PFN-A, UNKNOWN QUANTITY, UNKNOWN LOT UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, CHOY, WON-SIK, ET AL (2015) SURGICAL TREATMENT OF PATHOLOGICAL FRACTURES OCCURRING AT THE PROXIMAL FEMUR. YONSEI MED J 56(2):460-465, 2015. A RETROSPECTIVE STUDY OF NINETEEN PATIENTS WITH PERTROCHANTERIC AND SUBTROCHANTERIC METASTATIC PATHOLOGICAL FRACTURES WERE OPERATED ON BETWEEN 2006 AND 2012 AT A SINGLE INSTITUTION. THE MEAN AGE WAS 65.7 YEARS (RANGE, 42-87), THE PATIENTS COMPRISED 8 MALES AND 11 FEMALES. LONG PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA; SYNTHES, (B)(4)) OF THE CEPHALOMEDULLARY NAIL DEVICE WAS USED IN ALL CASES. POSTOPERATIVE COMPLICATIONS INCLUDED THE FOLLOWING: PATIENT 7, (B)(6) FEMALE WHO EXPERIENCED NAIL BREAKAGE REQUIRING REMOVAL OF THE BROKEN INTRAMEDULLARY NAIL, AND RESECTION OF THE PROXIMAL PART OF THE FEMUR FOLLOWED BY JOINT REPLACEMENT SURGERY WITH A BIPOLAR HEMIARTHROPLASTY. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN PROXIMAL FEMORAL NAIL ANTIROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485514 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention