BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2715643 · Received August 21, 2012

    Report

    Report Number
    2249697-2012-01310
    Event Type
    Injury
    Date Received
    August 21, 2012
    Date of Event
    July 30, 2012
    Report Date
    July 30, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    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

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT. CAT # NLS-300000B, LOT # 38307501, DESCRIPTION: LRG TAP PRI MOD NCK 0DEG 30MM. CAT # 540-11-46D, LOT # 38119001, DESCRIPTION: TRIDENT PSL HA SOLID BACK 46MM. CAT # 6570-0-132, LOT # 39131001, DESCRIPTION: DELTA V-40 CERAMIC HEAD 32/0. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA MKDKM5

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R