BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POROUS NEXGEN TM PATELLA, 32MM DIA.

    MDR report key: 3779458 · Received April 24, 2014

    Report

    Report Number
    3005751028-2014-00030
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 19, 2013
    Report Date
    April 24, 2014
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    JWH
    PMA / PMN Number
    K011904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNK WHICH LOT OF TM PATELLA WAS USED DURING THE INITIAL SURGERY, A REVIEW WAS CONDUCTED ON THE TWO POSSIBLE LOTS PROVIDED. THE MFG RECORDS INDICATE THAT THEY WERE MANUFACTURED TO SPECIFICATION. BASED ON THE INFO AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. SHOULD ADD'L INFO BE OBTAINED TO FURTHER THIS INVESTIGATION, THIS REPORT SHALL BE UPDATED.

    Description of Event or Problem · 1

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE NEXGEN LPS-FLEX. IT IS REPORTED BY THE PT 'S COUNSEL THAT THE PT RECEIVED A TM PATELLA ON (B)(6) 2011 AND WAS REVISED ON (B)(6) 2013 DUE TO PAIN; HOWEVER, THE SPECIFIC LOT NUMBER OF THE TM PATELLA USED FOR THE INITIAL SURGERY WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248415 POROUS NEXGEN TM PATELLA, 32MM DIA. TM PATELLA JWH ZIMMER TRABECULAR METAL TECHNOLOGY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention