BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIMMER MMC CUP 64MM/56MM CODE V

    MDR report key: 3783535 · Received April 16, 2014

    Report

    Report Number
    9613350-2014-03451
    Event Type
    Other
    Date Received
    April 16, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT IS CURRENTLY BEING MONITORED AND HAS NOT BEEN REVISED TO DATE. A LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS THE PT HAS NOT BEEN REVISED. ONCE THE PT UNDERGOES HIS PLANNED REVISION SURGERY AND THE PRODUCTS WILL BE RETURNED FOR INVESTIGATION AND THE RESULT OF THE INVESTIGATION IS MADE AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER REFERENCE NUMBER CPT(B)(4).

    Description of Event or Problem · 1

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE MMC ACETABULAR CUP. THE PT REPORTED THAT HE RECEIVED A ZIMMER MMC CUP 60MM/56MM CODE V, ALLOCLASSIC SL SCHAFT 6 12/14, METASUL LARGE DIAMETER HEAD 56/V AND HEAD ADAPTER M/0; 12/14-18/20 IMPLANTS, ON (B)(6) 2010. RECENT MARS MRI SHOWED FLUID BUILT UP. PT STATED THAT HE HAS PAINS SINCE THE SURGERY AND THE ION LEVEL IN HIS BLOOD FLUCTUATES. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2014. HE ALSO INDICATED HE IS A CLINICAL STUDY PT. NOTES: PT STATED THAT HE IS A CLINICAL STUDY PT. THE MRI PICTURE HAS NOT BEEN PROVIDED AND PT DID NOT SPECIFICALLY REPORTED IN WHAT CLINICAL STUDY HE IS TAKING PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233943 ZIMMER MMC CUP 64MM/56MM CODE V ZIMMER MMC CUP KWA ZIMMER GMBH 2518085

    Patients

    Seq Age Sex Outcome Treatment
    1 Other