BEUDAMED
    FDA Adverse Event Summary report: N

    ACTIVE KNEE

    MDR report key: 2900300 · Received December 19, 2012

    Report

    Report Number
    9618006-2012-00012
    Date Received
    December 19, 2012
    Date of Event
    October 1, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ADVANCED SURGICAL DESIGN AND MANUFACTURE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING RECEIPT OF INCIDENT REPORTS RELATING TO THE FAILED PATELLA, ASDM HAS RE-DESIGNED THE PATELLA COMPONENT TO INCLUDE A CENTRAL CIRCULAR RECESS (TO ACT AS A KEY-IN POINT FOR THE BONE CEMENT) AND INCREASE THE FILLET RADIUS BETWEEN THE PEG AND THE BASE WHICH HAS REMOVED THE OVERHANG ARTEFACT. ALL PATELLAS (NOT IMPLANTED) WITHIN THE FIELD HAVE BEEN REPLACED WITH THE NEW DESIGN. SURGEONS HAVE BEEN INFORMED OF THE POTENTIAL RISKS WITH THE OLD DESIGN OF THE PATELLA VIA PRODUCT NOTIFICATION SENT IN (B)(4) 2012. FOLLOWING RECEIPT OF FINAL INVESTIGATION REPORT, FURTHER INFO WAS DISSEMINATED TO SURGEONS IN (B)(4) 2012 BY WAY OF PRODUCT NOTIFICATION.

    Description of Event or Problem · 1

    PT PRESENTED WITH PAIN TO THE KNEE. PATELLA INSERT FOUND TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVE KNEE TOTAL KNEE REPLACEMENT JWH ADVANCED SURGICAL DESIGN AND MANUFACTURE

    Patients

    Seq Age Sex Outcome Treatment
    1