BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD 0DE 34MM

    MDR report key: 3541358 · Received December 20, 2013

    Report

    Report Number
    9616680-2013-90171
    Event Type
    Injury
    Date Received
    December 20, 2013
    Date of Event
    August 8, 2012
    Report Date
    December 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN SIMILAR EVENTS FOR THE REPORTED FAMILY. THE EVENT WAS CONFIRMED. A VOLUNTARY RECALL (B)(4) WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED EVENT IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE PATIENT WAS HAVING PAIN SO THE SURGEON REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668244 LRG TAP PRI MOD 0DE 34MM IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 38369301

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R