BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM PRESS-FIT COLLLARLESS

    MDR report key: 1190710 · Received October 6, 2008

    Report

    Report Number
    1822565-2008-00685
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    April 1, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ALLEGED COMPLAINTS REFERS TO UPPER TROCHANTER BURSITIS. THE FEMALE PATIENT HAS A BMI OF 41. IT IS PROBABLE THAT THE ADDITIONAL STRESS OF EXCESS BODY WEIGHT IS CONTRIBUTING TO THE PAINFUL/TENDERNESS OF THE HIP JOINT. THE DEVICES AND/OR X-RAYS WERE NOT PROVIDED FOR REVIEW. ALSO, LOT NUMBERS WERE NOT SUPPLIED. AN ENGINEERING ANALYSIS CAN NOT BE PERFORMED AT THIS TIME. H6: EVALUATION CODES: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT PRESENTED 6 MONTHS POST-OP WITH A COMPLAINT OF UPPER TROCHANTER BURSITIS, MARKING PROBABLY RELATED TO THE IMPLANTED DEVICE. OUTCOME AT THE TIME WAS PENDING. DEVICE WAS IMPLANTED IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM PRESS-FIT COLLLARLESS HIP PROSTHESIS KWY ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR