BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL FEMORAL STEM

    MDR report key: 1980178 · Received February 1, 2011

    Report

    Report Number
    1822565-2011-00147
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS UNKNOWN IF THE DEVICES HAVE BEEN REVISED. THE DEVICES WERE NOT RETURNED FOR EVALUATION, SO THEIR CONDITION IS UNKNOWN. SURGICAL NOTES FROM THE PRIMARY ARTHROPLASTY INDICATE THAT THERE WERE NO COMPLICATIONS. PATIENT DEMOGRAPHICS AND X-RAYS WERE NOT PROVIDED. IT IS UNKNOWN IF THE STEM WAS IMPLANTED WITH THE PROPER FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE. MATING INSTRUMENTATION USED DURING SURGERY IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT FOLLOWED THE PROPER REHABILITATION PROTOCOLS. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE A CAUSE FOR THIS ISSUE. 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. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL FEMORAL STEM HIP PROSTHESIS KWY ZIMMER, INC. 60679015

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other