BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3871922 · Received June 13, 2014

    Report

    Report Number
    2520274-2014-11727
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVENT: (B)(6) 2014. THIS REPORT FOR UNKNOWN PROXIMAL FEMORAL-LOCKING COMPRESSION PLATE, 4 HOLE PLATE, 4.5 MM 316-L, STAINLESS STEEL. , UNKNOWN PART#/LOT#. IMPLANT DATE: UNKNOWN. (B)(4). 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, "JOHNSON ET AL (MAY 2014). SHORT-TERM FOLLOW-UP OF PERTROCHANTERIC FRACTURES TREATED USING THE PROXIMAL FEMORAL LOCKING PLATE. J ORTHOP TRAUMA, VOLUME 28, NUMBER 5, 283-287. A RETROSPECTIVE ANALYSIS OF PATIENTS TREATED FOR INTERTROCHANTERIC AND SUBTROCHANTERIC FRACTURES OF THE PROXIMAL FEMUR USING THE PROXIMAL FEMORAL LOCKING COMPRESSION PLATE (PF-LCP) WAS CONDUCTED. THIRTY FOUR (34) PATIENTS WITH 34 FRACTURES UNDERWENT SURGICAL FIXATION USING THE PF-LCP. TWO PATIENTS WERE EXCLUDED AS THE PF-LCP WAS USED AS PART OF A REVISION PROCEDURE. THE MEAN AGE OF THE 32 PATIENTS WAS 75.6 YEARS (RANGE, 20¿100). TWENTY-TWO OF THE PATIENTS WERE FEMALE. SIX OF THE CASES INVOLVED, ¿HOOKED¿ PF-LCPS (SYNTHES), AND 26 WERE STANDARD PF-LCP¿S (SYNTHES). ALL SURGERIES WERE PERFORMED BY OR UNDER THE SUPERVISION OF CONSULTANT TRAUMA SURGEONS. NO PERIOPERATIVE COMPLICATIONS WERE ENCOUNTERED. SIX OF THE CASES INVOLVED, "HOOKED" PF-LCPS AND 26 WERE STANDARD PF-LCPS. NO PEROPERATIVE COMPLICATIONS WERE ENCOUNTERED. TWENTY-NINE PATIENTS ACHIEVED AT LEAST 12 MONTHS OF FOLLOW-UP (MEAN 23.7 MONTHS). THREE PATIENTS DIED DURING THIS PERIOD. THE FIRST DIED 2 WEEKS POSTOPERATIVELY FROM PNEUMONIA COMPLICATED BY ACUTE RENAL FAILURE. THE SECOND DIED OF METASTATIC CARCINOMATOSIS AND THE THIRD FROM ACUTE LEFT VENTRICULAR FAILURE AFTER A MYOCARDIAL INFARCTION. FIVE PATIENTS SUFFERED MULTIPLE MEDICAL COMPLICATIONS. TWELVE PATIENTS (12 FRACTURES) SUFFERED IMPLANT-RELATED COMPLICATIONS. THE MEAN AGE OF THESE PATIENTS WAS 83, AND 10 OF THE 12 PATIENTS WERE FEMALE. IT WAS REPORTED THAT THE LCP PLATE WAS SITTING TOO FAR OFF THE BONE WHICH CAUSED CUT-OUT OF THE PROXIMAL SCREWS IN A (B)(6) FEMALE POST-OPERATIVELY. THIS REPORT FOR UNKNOWN PROXIMAL FEMORAL-LOCKING COMPRESSION PLATE, UNKNOWN PART#/LOT#, 4 HOLE PLATE, 4.5 MM 316-L, STAINLESS STEEL. THIS IS REPORT 3 OF 20 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350466 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR