BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HGP FEMORAL STEM

    MDR report key: 2023280 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00578
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 16, 2010
    Report Date
    February 19, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICES WERE IN VIVO APPROXIMATELY 20 YEARS. NO PHOTOS OR X-RAYS WERE RECEIVED FROM THE INITIAL OR REVISION SURGERIES. NO SURGICAL NOTES WERE RECEIVED FROM THE REVISION. PT FACTORS SUCH AS ACTIVITY LEVEL AND BONE QUALITY ARE UNK. BECAUSE PROSTHETIC JOINTS ARE NOT AS STRONG, RELIABLE, OR DURABLE AS A NATURAL, HEALTHY JOINT, PROSTHETIC HIPS MAY NEED TO BE REPLACED. THE IMPLANT MAY NOT, AND IS NOT GUARANTEED TO, LAST THE REST OF THE PT'S LIFE, OR ANY SPECIFIED LENGTH OF TIME. IT IS MOST LIKELY THAT THE PERI-PROSTHETIC FRACTURE OF THE FEMUR WAS DUE TO PT FACTORS SUCH AS BONE QUALITY OR ACTIVITY LEVEL, WHICH ARE NOT IN THE CONTROL OF MANUFACTURER. NO CAUSE CAN BE DETERMINED. EVALUATION: 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR A PERI-PROSTHETIC FEMUR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGP FEMORAL STEM JDI ZIMMER, INC. 68246600

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention