BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2946176 · Received February 6, 2013

    Report

    Report Number
    0002249697-2013-00576
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. COMPLAINT HISTORY REVIEW: 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 REVISION IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED. NCR (B)(4) WAS INITIATED ON (B)(4) 2012 BECAUSE THE OCCURRENCE RATE FOR ADVERSE LOCAL TISSUE REACTION (ALTR) SPECIFIED IN THE RISK MANAGEMENT FILES FOR THE REJUVENATE MODULAR HIP SYSTEM WAS EXCEEDED. SEE CAPA (B)(4) FOR CORRECTIVE ACTIONS ASSOCIATED WITH THIS NCR. GIVEN THE POTENTIAL RISK OF FRETTING AND CORROSION WITH THESE DEVICES, VOLUNTARY PRODUCT RECALL RA 2012-067 WAS ISSUED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S LEFT REJUVENATE HIP DUE TO CORROSION AT THE NECK STEM JUNCTION. PATIENT HAS LEGAL REPRESENTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S LEFT REJUVENATE HIP DUE TO CORROSION AT THE NECK STEM JUNCTION. PATIENT HAS LEGAL REPRESENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50954 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention