BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HARRIS/GALANCE HIP

    MDR report key: 1871080 · Received October 12, 2010

    Report

    Report Number
    1822565-2010-00862
    Event Type
    Injury
    Date Received
    October 12, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO SPECIFIC PRODUCT INFO WAS PROVIDED. NO SURGICAL NOTES OR X-RAYS FROM EITHER THE PRIMARY OR REVISION SURGERY WERE PROVIDED. IT IS UNK IF THE PROPER SURGICAL TECHNIQUE WAS FOLLOWED. PT FACTORS SUCH AS WEIGHT AND ACTIVITY LEVEL ARE UNK. BASED ON THE VERY LIMITED INFO PROVIDED, A DEFINITIVE CAUSE FOR FAILURE CANNOT BE DETERMINED WITH CERTAINTY. REVIEW OF THE DEVICE HISTORY RECORDS WAS 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 INFO, 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 PT WAS REVISED FOR AN UNK REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN HARRIS/GALANCE HIP HIP PROSTHESIS KWY ZIMMER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention