BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM BEADED FULLCOAT COLLARED

    MDR report key: 1081767 · Received July 25, 2008

    Report

    Report Number
    1822565-2008-00776
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    January 29, 2008
    Report Date
    October 9, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ALLEGED COMPLAINT REFERS TO A FRACTURE OF THE PT'S FEMORAL NECK (BONE) ON THE SAME DAY THAT A VERSYS BEADED FULLCOAT STEM WAS IMPLANTED. X-RAYS AND/OR PHOTOS WERE NOT RECEIVED FOR REVIEW. THERE WAS NO INFO PROVIDED IN REGARDS TO THE ADVERSE SURGICAL DETAILS, OR SUB PAR BONE QUALITY. THE PT WAS REPORTED TO HAVE "POST-TRAUMATIC ARTHRITIS" AND CANCER. BASED ON THE INFO PROVIDED THE CAUSE CAN NOT BE DETERMINED WITH CERTAINTY. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2008. THE PT EXPERIENCED FRACTURE OF THE FEMORAL NECK SAME DAY AS IMPLANTED. TREATMENT WAS ORIF WITH CABLE READY PLATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL STEM BEADED FULLCOAT COLLARED HIP PROSTHESIS LPH ZIMMER, INC. NA 60446851

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR