BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACET CMPNT 54/48 N

    MDR report key: 8549172 · Received April 25, 2019

    Report

    Report Number
    0009613350-2019-00260
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    May 15, 2018
    Report Date
    April 25, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    K053536
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: METASUL LARGE DIAMETER HD 48/N CATALOG #: 0100181480 LOT #: 2341597. ITEM: HEAD ADAPTER M/0 12/14-18/20 CATALOG #: 0100185146 LOT #: 2424831. ITEM: ZIMMER® M/L TAPER HIP PROSTHESIS CATALOG #: 00-7711-07-10 LOT #: 60832080. DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER (B)(4) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BECOMES AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ELEVATED COBALT AND CHROMIUM ION LEVELS, FLUID COLLECTION AND LOCAL TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345666 DUROM US ACET CMPNT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS KWA ZIMMER GMBH N/A 2403659

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R