BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 42MM

    MDR report key: 2933524 · Received January 29, 2013

    Report

    Report Number
    0002249697-2013-00411
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDED PATIENT DEMOGRAPHICS. DEVICE INFORMATION WAS RECEIVED. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: 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. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS UNKNOWN REJUVENATE MODULAR NECK. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING TROCHANTERIC PAIN INVOLVING AN UNKNOWN REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. SIMILAR EVENTS HAVE OCCURRED FOR THE REJUVENATE MODULAR 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 TROCHANTERIC PAIN IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    THE PATIENT IS EXPERIENCING TROCHANTERIC PAIN. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 10 MONTHS SINCE INDEX SURGERY: COBALT - 1.8; CHROMIUM - 0.2. FURTHER FOLLOW UP IS PLANNED FOR THIS PATIENT.

    Description of Event or Problem · 1

    THE PATIENT IS EXPERIENCING TROCHANTERIC PAIN. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 10 MONTHS SINCE INDEX SURGERY: COBALT - 1.8; CHROMIUM - 0.2. FURTHER FOLLOW UP IS PLANNED FOR THIS PATIENT

    Description of Event or Problem · 1

    THE PATIENT IS EXPERIENCING TROCHANTERIC PAIN. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 10 MONTHS SINCE INDEX SURGERY: COBALT - 1.8; CHROMIUM - 0.2. FURTHER FOLLOW UP IS PLANNED FOR THIS PATIENT. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON: ELEVATED COBALT AND CHROMIUM ION LEVELS AND LATERAL HIP PAIN; DIAGNOSED AS ADVERSE LOCAL TISSUE REACTION RELATED TO THE DEVICE. EVEN BECOME SERIOUS ON (B)(6) 2013 AND THE SUBJECT WAS REVISED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38931 LRG TAP PRI MOD NCK 0DEG 42MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other