BEUDAMED
    FDA Adverse Event Other Summary report: N

    METASUL HEAD 40, 12/14, SIZE M/0

    MDR report key: 3993776 · Received July 8, 2014

    Report

    Report Number
    9613350-2014-03750
    Event Type
    Other
    Date Received
    July 8, 2014
    Date of Event
    January 18, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PATIENT HAS NOT BEEN REVISED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ONCE MORE DETAILED INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED. ZIMMER'S REFERENCE NUMBER OF THIS CASE IS (B)(4). NOTES: THE CONTINUUM SHELL, CLUSTER, 54 JJ IS A ZIMMER (B)(4) PRODUCT AND WILL BE REPORTED UNDER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A METASUL HEAD 40, 12/14, SIZE M/0 ON (B)(6) 2012 ON THE LEFT SIDE. THE HEAD WAS IMPLANTED IN COMBINATION WITH A METASUL TAPER LINER, JJ/40, A CONTINUUM SHELL, CLUSTER, 54 JJ AND AN M/L TAPER SIZE 5.0 EXTENDED OFFSET. ON (B)(6) 2014 THE PATIENT SHOWED CLINICALLY ILEOPSOAS TENDINITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398264 METASUL HEAD 40, 12/14, SIZE M/0 METASUL HEAD 40, 12/14, SIZE M/0 KWA ZIMMER GMBH 2627484

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other