BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9

    MDR report key: 2711220 · Received August 15, 2012

    Report

    Report Number
    2249697-2012-01288
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 7, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT ID IS NOT VALID FOR THE REPORTED DEVICE. CAT NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: DESC: RESTORATION ADM X3 INS 28/54: CAT# 1236-2-854, LOT# 36297801. DESCP: RESTORATION (TM) ADM. CUP W/HA: CAT # 1235-2-541, LOT# G3057945. DESCP: LRG TAP PRI MOD NCK 0DEG 30MM: CAT # NLS-300000B, LOT# 37106301. DESC: 28MM-4 LFIT V40 HEAD: CAT # 6260-9-028, LOT# 36580602. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S EXPERIENCE. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R