BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER FEMORAL STEM

    MDR report key: 2103842 · Received May 24, 2011

    Report

    Report Number
    1822565-2011-01229
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE EXACT DURATION OF IN VIVO TIME IS UNK BUT ACCORDING TO THE REPORT, THE IMPLANTS COULD HAVE BEEN IMPLANTED APPROXIMATELY 10 YEARS AGO. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. EVAL: 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 FEMORAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER FEMORAL STEM HIP PROSTHESIS KWY ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention