BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6856169 · Received September 11, 2017

    Report

    Report Number
    2520274-2017-12245
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    July 8, 2017
    Report Date
    August 28, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN ¿ 4 HOLE LOCKING ATTACHMENT PLATE (LAP)/UNKNOWN QUANTITY/UNKNOWN LOT. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE KIM, M., CHO, J., LEE, Y., SHON, W., PARK, J., KIM, J. AND OH, J. (2017) LOCKING ATTACHMENT PLATE FIXATION AROUND A WELL-FIXED STEM IN PERIPROSTHETIC FEMORAL SHAFT FRACTURES. ARCH ORTHOP TRAUMA SURG, DOI 10.1007/S00402-017-2745-4. THE PURPOSE OF THIS ARTICLE IS TO REPORTS THE CLINICAL RESULTS USING A LOCKING ATTACHMENT PLATE (LAP) INSTEAD OF CABLE FIXATION TO FIX LOCKING PLATES TO A PERIPROSTHETIC FEMORAL SHAFT FRACTURE. THIS RETROSPECTIVE STUDY REVIEWED CASES BETWEEN AUGUST 2012 AND DECEMBER 2014. THE STUDY INCLUDED NINETEEN (19) PATIENTS WHICH CONSISTED OF FIVE (5) MALE PATIENTS AND FOURTEEN (14) FEMALE PATIENT WITH A MEAN AGE OF 74 YEARS (RANGE 56-96 YEARS). THE AVERAGE FOLLOW-UP WAS 16 MONTHS (RANGE 12-36 MONTHS). A COPY OF THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ¿ 4 HOLE LOCKING ATTACHMENT PLATE (LAP) AND REFERS TO ONE (1) UNKNOWN PATIENT NEEDED IV ANTIBIOTIC THERAPY FOR SURGICAL SITE INFECTION. ONE (1) UNKNOWN PATIENT UNDERWENT SURGERY FOR INFECTION OF BIPOLAR HIP ARTHROPLASTY, BUT THERE WAS NO EVIDENCE OF INFECTION AT THE FRACTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635298 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention