BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 3112316 · Received May 14, 2013

    Report

    Report Number
    0002249697-2013-01670
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MDR WAS MISTAKENLY SUBMITTED TO FDA THROUGH NORMAL ELECTRONIC FILING. THIS MDR WILL BE RESUBMITTED VIA A QUARTERLY SUMMARY REPORT AS PART OF THE REQUIREMENT OF REMEDIAL ACTION EXEMPTION #(B)(4), GRANTED TO STRYKER BY FDA ON (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN REJUVENATE STEM. A VOLUNTARY RECALL (B)(4) WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. LEGAL CASE

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING ALTR 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 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 ALTR IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS PER LEGAL CORRESPONDENCE, LAW FIRM REPRESENTS PATIENT, RECIPIENT OF A STRYKER REJUVENATE REPLACEMENT HIP. LAW FIRM STATES THE LETTER IS A DIRECT NOTICE FROM THEIR CLIENTS OF ANY AND ALL DEFECTS IN THE AFOREMENTIONED PRODUCT, INCLUDING BUT NOT LIMITED TO FRETTING AND/OR CORROSION AT OR ABOUT THE MODULAR NECK JUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS PER LEGAL CORRESPONDENCE, LAW FIRM REPRESENTS PATIENT, RECIPIENT OF A STRYKER REJUVENATE REPLACEMENT HIP. LAW FIRM STATES ATTACHED LETTER IS A DIRECT NOTICE FROM THEIR CLIENTS OF ANY AND ALL DEFECTS IN THE AFOREMENTIONED PRODUCT, INCLUDING BUT NOT LIMITED TO FRETTING AND/OR CORROSION AT OR ABOUT THE MODULAR NECK JUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS PER LEGAL CORRESPONDENCE, LAW FIRM REPRESENTS PATIENT, RECIPIENT OF A STRYKER REJUVENATE REPLACEMENT HIP. LAW FIRM STATES ATTACHED LETTER IS A DIRECT NOTICE FROM THEIR CLIENTS OF ANY AND ALL DEFECTS IN THE AFOREMENTIONED PRODUCT, INCLUDING BUT NOT LIMITED TO FRETTING AND/OR CORROSION AT OR ABOUT THE MODULAR NECK JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212038 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH MJNHN4

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other