BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 30MM

    MDR report key: 2913026 · Received January 14, 2013

    Report

    Report Number
    0002249697-2013-00033
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL 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. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO PAIN AND SWELLING INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: 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 REVISION DUE TO PAIN AND SWELLING IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON DID A REJUVENATE REVISION ON PATIENT'S RIGHT HIP BECAUSE PATIENT HAD INEXPLICABLE PAIN AND SWELLING OF THEIR HIP. SURGEON REMOVED STEM, NECK, HEAD AND ADM POLY LINER. SURGEON REPLACED WITH A NEW STRYKER ADM LINER AND REPLACED STEM/HEAD WITH ZIMMER COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON DID A REJUVENATE REVISION ON PATIENT'S RIGHT HIP BECAUSE PATIENT HAD INEXPLICABLE PAIN AND SWELLING OF THEIR HIP. SURGEON REMOVED STEM, NECK, HEAD AND ADM POLY LINER. SURGEON REPLACED WITH A NEW STRYKER ADM LINER AND REPLACED STEM/HEAD WITH ZIMMER COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20170 LRG TAP PRI MOD NCK 0DEG 30MM IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 34095601

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention