BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/0

    MDR report key: 4943486 · Received July 27, 2015

    Report

    Report Number
    0002249697-2015-02468
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    December 1, 2014
    Report Date
    April 6, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT THE IMPLANTED DEVICES WERE EITHER ABG II OR REJUVENATE AND THE REPORT WAS PREPARED FOR OUR QUARTERLY SUBMISSION. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON JULY 2, 2015 CONFIRMED THAT THE DEVICES WERE NEITHER ABG II NOR REJUVENATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ELEVATED ION LEVELS INVOLVING A METAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO PRODUCTS WERE RETURNED FOR INVESTIGATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND NO PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS PAIN WHEN SLEEPING AT NIGHT CAN'T TURN OVER, WHEN GETTING UP FROM SITTING POSITION HIP FEELS LIKE ITS SLIPPING, RASHES. ADDITIONAL INFORMATION RECEIVED ON 05/01/2015: THE PATIENT STATED THAT HER SURGEON IS PERFORMING MORE TESTS BUT THAT SHE WILL NEED A REVISION TO REPLACE THE BALL. THE PATIENT WAS UNABLE TO PROVIDE ANY FURTHER DETAIL AT THE TIME OF THE CALL BUT REQUESTED A CALL BACK ON MONDAY TO DISCUSS OUR PROCESS. ON (B)(6) 2015, THE PATIENT PROVIDED HER IMPLANT SHEET WHICH IDENTIFIED THE DEVICES INVOLVED. THE PATIENT INDICATED THAT SHE HAS ELEVATED COBALT LEVELS AND HAS NOT BEEN THE SAME SINCE THE DEVICES WERE IMPLANTED. DEVICES HAVE NOT BEEN EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS PAIN WHEN SLEEPING AT NIGHT CAN'T TURN OVER, WHEN GETTING UP FROM SITTING POSITION HIP FEELS LIKE ITS SLIPPING, RASHES. ADDITIONAL INFORMATION RECEIVED ON 05/01/2015: THE PATIENT STATED THAT HER SURGEON IS PERFORMING MORE TESTS BUT THAT SHE WILL NEED A REVISION TO REPLACE THE BALL. THE PATIENT WAS UNABLE TO PROVIDE ANY FURTHER DETAIL AT THE TIME OF THE CALL BUT REQUESTED A CALL BACK ON MONDAY TO DISCUSS OUR PROCESS. ON 07/02/2015, THE PATIENT PROVIDED HER IMPLANT SHEET WHICH IDENTIFIED THE DEVICES INVOLVED. THE PATIENT INDICATED THAT SHE HAS ELEVATED COBALT LEVELS AND HAS NOT BEEN THE SAME SINCE THE DEVICES WERE IMPLANTED. DEVICES HAVE NOT BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486027 V40 COCR LFIT HEAD 36MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MHEX0M

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other