BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2705600 · Received August 13, 2012

    Report

    Report Number
    2249697-2012-01209
    Event Type
    Injury
    Date Received
    August 13, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 1, 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-340000B, LOT# 38893902, DESCRIPTION: ERG TAP PRI MOD NCK 0DEG 34MM; CAT # 6570-0-436, LOT# 39149901, DESCRIPTION: DELTA V-40 CERAMIC HEAD 36/-2,5; CAT# 540-11-52E, LOT# 38325501, DESCRIPTION: TRIDENT PSL HA SOLID BACK 52MM; CAT# 623-00-36E, LOT# MLA51Y, DESCRIPTION: TRIDENT 0 X3 INSERT 36MM ID. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S EXPERIENCE. ADDITIONAL 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 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 MKE4XV

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R