BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE MODULAR STEM

    MDR report key: 2926219 · Received January 16, 2013

    Report

    Report Number
    2249697-2013-90148
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    January 2, 2020
    Report Date
    February 21, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    Z-2090-2012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REASON FOR STERILIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT RECEIVED NOTIFICATION FROM SURGEON ABOUT HIP RECALL. PT IS REPORTING HAVING PAIN IN HIS HIP. PT ALSO STATES THAT HE CANNOT LIFT LEG MORE THAN EIGHT INCHES OFF GROUND AND THAT IT IS PAINFUL SITTING DOWN AND GETTING UP FROM A SEATED POSITION. PT HAS NOT BEEN TO SEE A SURGEON YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23553 UNKNOWN REJUVENATE MODULAR STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH STRYKER ORTHOPAEDICS-MAHWAH NA UNKNOWN
    23658 UNKNOWN REJUVENATE MODULAR STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH STRYKER ORTHOPAEDICS-MAHWAH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R| O NA.