BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPONENT 60/54 CODE T

    MDR report key: 4046783 · Received August 26, 2014

    Report

    Report Number
    9613350-2014-03820
    Event Type
    Other
    Date Received
    August 26, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS FOR REVIEW, AS THE PATIENT IS CURRENTLY BEING MONITORED AND HAS NOT BEEN REVISED TO DATE. THE LAB REPORT HAS BEEN PROVIDED TO REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN NOVEMBER 2009. AN UPDATED REPORT WILL BE SUBMITTED ONCE SUBSTANTIAL FOLLOW UP INFO IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT WAS IMPLANTED WITH A DUROM ACETABULAR COMPONENT 60/54 CODE T, HEAD ADAPTER M/0; 12/14-18/20, METASUL LARGE DIAMETER HEAD 54/T AND A HIP-VER-IMP-STM-PRS-FML-SDO-CLL-HAT ON (B)(6) 2006. SURGEON DISCUSSED WITH THE PATIENT THAT A REVISION IS NECESSARY. HE INDICATED THE REASON FOR REVISION WAS DUE TO INCREASE IN CR LEVELS AND METALIC TASTE IN PATIENTS MOUTH. REVISION SURGERY HAS BEEN BOOKED FOR (B)(6) 2014. THE PATIENT IS ALSO REPORTED TO HAVE PAIN AND IS EXPERIENCING OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518468 DUROM ACETABULAR COMPONENT 60/54 CODE T DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2292485

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other