BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PRECOAT STEMMED TIBIAL LCCK

    MDR report key: 6211807 · Received December 28, 2016

    Report

    Report Number
    0002648920-2016-04407
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    November 23, 2016
    Report Date
    April 20, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: NEXGEN LCCK ARTICULAR SURFACE SIZE YELLOW/ C D 10MM, ITEM NUMBER: 00599403010, LOT NUMBER: NI. ITEM NAME: NEXGEN STEM OFFSET 11 MM X 100MM, ITEM NUMBER: 00598802011, LOT NUMBER: 61315854. ITEM NAME: PALACOS G + R BONE CEMENT, ITEM NUMBER: NI, LOT NUMBER: NI.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO FRACTURED SAFETY SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858403 NEXGEN PRECOAT STEMMED TIBIAL LCCK PROTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 61351058

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR