BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2930027 · Received January 25, 2013

    Report

    Report Number
    0002249697-2013-00284
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    November 21, 2011
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS NO DEVICES WERE RETURNED FOR EVALUATION. REVIEW OF THE MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED, THE INDICATION FOR THE REVISION SURGERY IS NOT CLEAR AND THE SOURCE OF THE PAIN IS NOT DEMONSTRATED TO BE RELATED TO EITHER THE PRIMARY OR REVISION COMPONENTS. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE SOURCE OF THE PAIN WAS NOT CLEAR AND IT IS NOT DEMONSTRATED TO BE RELATED TO EITHER THE PRIMARY OR REVISION COMPONENTS.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN LEFT STRYKER HIP.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. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT HAD REVISION SURGERY ON (B)(6) 2011. PATIENT STATES THAT HE HAS BEEN IN A LOT OF PAIN SINCE HAVING REVISION SURGERY. PATIENT STATES THAT THE PAIN IS IN HIS HIP JOINT. PATIENT HAS HAD X-RAYS AND MRI DONE. PATIENT STATES THAT HE WAS VERY ACTIVE PRIOR TO HIS SURGERIES AND NOW HE HAS TROUBLE GETTING AROUND. PATIENT WAS (B)(6) WHEN THE EVENT OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT HAD REVISION SURGERY ON (B)(6) 2011. PATIENT STATES THAT HE HAS BEEN IN A LOT OF PAIN SINCE HAVING REVISION SURGERY. PATIENT STATES THAT THE PAIN IS IN HIS HIP JOINT. PATIENT HAS HAD X-RAYS AND MRI DONE. PATIENT STATES THAT HE WAS VERY ACTIVE PRIOR TO HIS SURGERIES AND NOW HE HAS TROUBLE GETTING AROUND. PATIENT WAS (B)(6) WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36065 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other