BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLIANCE HIP GENERIC

    MDR report key: 2933228 · Received January 8, 2013

    Report

    Report Number
    9613350-2013-01226
    Event Type
    Other
    Date Received
    January 8, 2013
    Date of Event
    July 23, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS VERY UNCLEAR. THE REPORT DID NOT MENTION IF THE PRODUCT IS A ZIMMER PRODUCT AND FURTHER, NO PRODUCT OR LOT NUMBER IS KNOWN. THE DATE OF SURGERY IS ALSO UNKNOWN. JUST BECAUSE IT IS A LEGAL CASE, WE ARE REPORTING THIS COMPLAINT. THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. HOWEVER, SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICES BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTH INSURANCE COMPANY THAT THE PT RECEIVED AN ALLIANCE HIP GENERIC ON AN UNKNOWN DATE. IT WAS FURTHER REPORTED THAT THE IMPLANT BROKE "WHILE THE PT CLIMBED UP THE STAIRS". IT IS UNKNOWN AT THIS TIME IF A REVISION SURGERY HAS TAKEN PLACE OR IS IN DISCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10245 ALLIANCE HIP GENERIC ALLIANCE GENERIC KWY ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other