BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2155014 · Received June 28, 2011

    Report

    Report Number
    9613350-2011-00419
    Event Type
    Other
    Date Received
    June 28, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. SINCE NO LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION CURRENTLY PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. ZIMMER GMBH CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT COMPLAINED OF INCREASED PAIN LOCATED ON THE RIGHT HIP RIGHT AFTER SURGERY, WHICH IMPROVED FOR ABOUT ONE YEAR. IT IS ALSO REPORTED THAT THE PATIENT STATED THAT SHE HAD NEVER REGAINED FULL STRENGTH AFTER SURGERY. RECENTLY, THE PATIENT HAD AN X RAY EXAMINATION AND REPORTED THAT HER DOCTOR OBSERVED SOME SEPARATION AND THE NEED FOR A FUTURE SURGICAL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other