BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10

    MDR report key: 2914006 · Received January 14, 2013

    Report

    Report Number
    0002249697-2013-00044
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING CORROSION INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE SUPER AND CHS COMPLAINT DATABASES SHOW THERE HAVE BEEN OTHER EVENTS FOR THE REPORTED LOT. SIMILAR EVENTS HAVE OCCURRED FOR THE CATALOG NUMBER AND PRODUCT FAMILY. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH RA 2012-067. VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED CORROSION IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S RIGHT REJUVENATE HIP DUE TO CORROSION AT THE NECK STEM JUNCTION. THE CUP REMAINED IN AS SURGEON SAID IT WAS WELL FIXED. SURGEON REPLACED WITH A RESTORATION MODULAR STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S RIGHT REJUVENATE HIP DUE TO CORROSION AT THE NECK STEM JUNCTION. THE CUP REMAINED IN AS SURGEON SAID IT WAS WELL FIXED. SURGEON REPLACED WITH A RESTORATION MODULAR STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21435 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MHTP6X

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention