BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT TMZF MOD STEM SIZE 8

    MDR report key: 2821428 · Received October 23, 2012

    Report

    Report Number
    2249697-2012-02001
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    January 20, 2012
    Report Date
    September 28, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: REJUVENATE MODULAR NECK 30MM V40, CAT# NLV-300800G, LOT #38248301. TRITANIUM REVISION ACETABULAR, CAT #509-02-54E, LOT# MKP69V. TRIDENT 10DEG CROSSFIRE INSERT 36MM ID, CAT# 621-10-36E, LOT# MKP4LL. OSTEOLOCK BONE SCREW 35MM, CAT# 5260-5-035, LOT# 38323402. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. HOWEVER, SOME X-RAYS AND MEDICAL RECORDS HAVE BEEN RECEIVED. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; PATIENT COMPLAINS OF MINOR PAIN, PAIN WHILE LYING DOWN. MRI AND BLOOD TEST ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT TMZF MOD STEM SIZE 8 IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MKR6H8

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other