BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE MODULAR NECK

    MDR report key: 2915594 · Received January 10, 2013

    Report

    Report Number
    9616680-2013-90082
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    April 19, 2010
    Report Date
    December 20, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN SIMILAR EVENTS FOR THE REPORTED FAMILY. THE EVENT WAS CONFIRMED. A VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGIL AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED EVENT IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT LEARNED OF THE RECALL FROM SURGEON. PATIENT COMPLETED BLOOD TEST AND MRI. TEST RESULTS SHOW FLUID ON TH HIP AND LOW METAL LEVELS. THE PATIENT WILL FOLLOW-UP WITH SURGEON IN SIX MONTHS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT LEARNED OF THE RECALL FROM SURGEON. PATIENT COMPLETED BLOOD TEST AND MRI. TEST RESULTS SHOW FLUID ON THE HIP AND LOW METAL LEVELS. THE PATIENT WILL FOLLOW-UP WITH SURGEON IN SIX MONTHS. ADDITIONAL INFORMATION: PLAINTIFF ALLEGES THE RIGHT REJUVENATE HIP IMPLANTED ON (B)(6) 2010 FAILED CAUSING PAIN AND ELEVATED METAL ION LEVELS. PLAINTIFF HAS NOT YET SCHEDULED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13692 REJUVENATE MODULAR NECK IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 24944802

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other