BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 2050651 · Received April 12, 2011

    Report

    Report Number
    8010764-2011-00016
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 2011
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPEDIC DIVISION-GERMANY
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT WAS RETURNED AND EVALUATED. DIMENSIONAL INSPECTION OF THE 3 TIBIAL BASES INDICATED THEY WERE WITHIN SPECIFICATION AND NO MANUFACTURING OR MATERIAL DEVIATIONS WERE NOTED. TWO INSERTS WERE RETURNED. DIMENSIONAL INSPECTION OF THE FIRST INSERT INDICATED IT WAS WITHIN SPECIFICATION. THE 2 INSERT HAD DEFORMATIONS ON TWO ATTRIBUTES WHICH PREVENTED ACCURATE DIMENSIONAL ANALYSIS. THESE DEFORMATIONS WERE MOST LIKELY CAUSED DURING INSERTION ATTEMPTS WITH THE TIBIAL BASE. ALL OTHER ATTRIBUTES WERE WITHIN SPECIFICATION. NO MATERIAL OR MANUFACTURING DEVIATIONS WERE NOTED ON THE INSERTS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT SURGERY TIME WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II INSERT JWH SMITH & NEPHEW, INC. ORTHOPEDIC DIVISION-GERMANY 09GT33689

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization (B)(4)| (B)(4)| PART # 71420168, LOT # 10DT41898