BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9

    MDR report key: 2682854 · Received August 1, 2012

    Report

    Report Number
    2249697-2012-01073
    Event Type
    Injury
    Date Received
    August 1, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: LRG TAP PRI MOD NCK 8 DEG 38MM, CAT# NLV-380800G, LOT# 31714901. TRIDENT PSL WITH PUREFIX HA 64 MM, CAT# 542-11-64H, LOT# 32026701. TRIDENT 0 DEG INSERT 44 MM, CAT# 623-00-44H, LOT# MHPETP. UNI ADAPTOR SLEEVE V40 TI, CAT# 6519-7-100, LOT# 34630806. DELTA UN.FEM HD 44 MM, CAT# 6519-1-044, LOT# 34967401. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: DR. (B)(6) STATED THE PT HAD PAIN STARTING (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other