BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL KNEE II PATELLA FEMORAL COMPONENT

    MDR report key: 2774598 · Received September 28, 2012

    Report

    Report Number
    1822565-2012-02004
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    February 22, 2012
    Report Date
    August 30, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: REVIEW OF SURGICAL REPORTS PROVIDED INDICATES SURGICAL TECHNIQUE WAS FOLLOWED. X-RAYS WERE RECEIVED, SHOWING THAT THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT IRRIGATION AND DEBRIDEMENT WITH DRAIN PLACEMENT DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE II PATELLA FEMORAL COMPONENT HTG ZIMMER, INC. 60471615

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention OSTEOBOND DOUGH-TYPE RADIOPAQUE BONE CEMENT:| CAT # 00110100800, LOT #60700415