BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIPOLAR BIPOLAR CUP

    MDR report key: 2051509 · Received April 7, 2011

    Report

    Report Number
    1822565-2011-00870
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    June 11, 2008
    Report Date
    March 11, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE FEMORAL HEAD IS A NON-ZIMMER DEVICE AND THE STEM IS ALSO THOUGHT TO BE NON-ZIMMER BUT CANNOT BE CONFIRMED. SURGICAL NOTES FROM WHEN THE DEVICES WERE EXPLANTED REVEALED THAT THE CUP WAS LOOSE ONCE THE ACETABULAR SCREW WAS REMOVED. THE STEM AND CUP MOST LIKELY HAVE BEEN IN THE PT SINCE HIS SURGERY IN (B)(6) 1998. THE OTHER COMPONENTS (CUP, LINER, HEAD, AND HEAD ADAPTOR) WERE IN VIVO FOR APPROXIMATELY 6.5 YRS AT THE TIME OF REVISION. IT IS NOT RECOMMENDED TO USE ZIMMER DEVICES WITH NON-ZIMMER DEVICES AS THEY ARE NOT TESTED AS SUCH. IT IS UNK EXACTLY WHY THE CUP BECAME LOOSE WITHIN THE PT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO LOOSENING OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPOLAR BIPOLAR CUP JDG ZIMMER, INC. 76928200

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention CAT#32856021127, LOT#35203600| VERSYS ENDO FEMORAL HEAD ADAPTER, CAT#00781809902,| LOT#77241400| TRILOGY LONGEVITY CROSSLINKED POLYETHYLENE LINER,