BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE STEM

    MDR report key: 2922632 · Received January 15, 2013

    Report

    Report Number
    2249697-2013-90141
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    March 5, 2009
    Report Date
    December 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION 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 THROUGH (B)(4): I HAD A TOTAL HIP REPLACEMENT ON 2009. I RECEIVED A STRYKER REJUVENATE SPT. PRIOR TO THIS SURGERY, I HAD PAIN AND CATCHING/CLICKING IN MY RIGHT HIP. IT WAS VERY PAINFUL TO RIDE IN ANY VEHICLE. THE PAIN WAS AFFECTING MY KNEES AS I TRIED TO FAVOR MY HIP. ALL THIS INCREASED SINCE THE SURGERY, PLUS THE WEAKNESS IN MY HIP. I HAD TO LEARN TO SLEEP ON MY BACK AS TURNING WAS A BIG PROBLEM AND SLEEPING ON MY SIDE IMPOSSIBLE. I HAVE HAD MANY ROUND OF PT OVER THE LAST 3+ YEARS AND MANY BOUTS OF BURSITIS, AT LEAST 4 TIMES SWELLING TO THE SIZE OF A TENNIS BALL. NONE OF THE PT OR EXERCISES SEEMED TO STRENGTHEN THE MUSCLES IN MY RIGHT HIP. MY RIGHT HIP DISLOCATED ON 2011, AS I WAS SITTING IN A CHAIR PUTTING ON A PAIR OF SHOES. I WAS TAKEN BY AMBULANCE TO THE HOSPITAL AND HAD TO STAY OVERNIGHT. IN 2012, I GOT THE LETTER OF THE RECALL AND WENT IN FOR MRI AND BLOOD TEST, IT WAS CONFIRMED I HAD A VERY HIGH LEVEL OF HEAVY METAL POISONING. PT FROM 2009 THROUGH 2012. REASON FOR USE: ADVANCED RIGHT HIP ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22224 UNKNOWN REJUVENATE STEM IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention