BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 8DEG 34MM

    MDR report key: 2940820 · Received February 4, 2013

    Report

    Report Number
    0002249697-2013-00534
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALTR INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. A DEVICE HISTORY REVIEW FOUND THAT 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 ALTR IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. (B)(6) REVISED A REJUVENATE STEM AND NECK. PATIENT HAD NOTABLE PAIN SYMPTOMS APPROXIMATELY 6 MONTHS POST OP. DR. (B)(6) HAD DONE A CONTRASTING MRI ON THE PATIENT AND IT SHOWED AN AREA OF CONCERN. DR. (B)(6) WORKED ON THE REMOVAL PROCESS AND IT WAS VERY DIFFICULT. AFTER 90 MINUTES AND AGGRESSIVE USE OF REMOVAL TOOLS AND FLEXIBLE OSTEOTOME, THE STEM WAS EXTRACTED. HE REIMPLANTED A SECUR-FIT STEM AND HEAD. THE PATIENT'S CHROMIUM LEVEL WAS 7.6.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. (B)(6) REVISED A REJUVENATE STEM AND NECK. PATIENT HAD NOTABLE PAIN SYMPTOMS APPROXIMATELY 6 MONTHS POST OP., DR. (B)(6) HAD DONE A CONTRASTING MRI ON THE PATIENT AND IT SHOWED AN AREA OF CONCERN. DR. B. WORKED ON THE REMOVAL PROCESS AND IT WAS VERY DIFFICULT. AFTER 90 MINUTES AND AGGRESSIVE USE OF REMOVAL TOOLS AND FLEXIBLE OSTEOTOME, THE STEM WAS EXTRACTED. HE REIMPLANTED A SECUR-FIT STEM AND HEAD. THE PATIENT'S CHROMIUM LEVEL WAS 7.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47129 LRG TAP PRI MOD NCK 8DEG 34MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 25519701

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention