BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTILO PRESSFIT-HAK CEDIOR 48

    MDR report key: 4257585 · Received November 14, 2014

    Report

    Report Number
    9613350-2014-04114
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    February 4, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE EXPLANTED DEVICE OR X-RAYS FOR REVIEW. LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. AS SOON AS ADDITIONAL INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED A COTILO PRESSFIT-HAK CEDIOR 48 ON THE RIGHT SIDE ON (B)(6) 2006. IT WAS REPORTED THAT THE PT EXPERIENCED PAIN AND AN ARTICULAR PSEUDO-CYSTE WITH SYNOVIAL METALLOSIS WAS DIAGNOSED. REVISION SURGERY TOOK PLACE ON (B)(6) 2014 AND THE CUP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738217 COTILO PRESSFIT-HAK CEDIOR 48 COTILO PRESSFIT-HAK CEDIOR 48 KWA ZIMMER GMBH NA 4006090

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R