BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SEAS AUGMENT

    MDR report key: 7306172 · Received March 1, 2018

    Report

    Report Number
    0001825034-2018-01415
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    September 23, 2013
    Report Date
    June 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01409, 0001825034 - 2018 - 01410, 0001825034 - 2018 - 01411, 0001825034 - 2018 - 01412, 0001825034 - 2018 - 01413, 0001825034 - 2018 - 01414. CONCOMITANT MEDICAL PRODUCTS: 211224 COMPR SRS IC SEG - 30MM, UNKNOWN LOT, 211237 COMPR SRS MOD STEM - 10X100MM, UNKNOWN LOT, 211253 COMPR SRS 50MM DST HML BDY RT, UNKNOWN LOT, UNKNOWN PART/LOT; PROXIMAL BODY, REGENERX AUGMENT, PPS AUGMENT. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN THE (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FOUND IT SEVERELY DIFFICULT TO OPEN JAR, DO HEAVY CHORES, CARRY BAG, WASH BACK, CUT GRASS, PERFORM SOCIAL ACTIVITIES, AND PERFORM DAILY ACTIVITIES. THE PATIENT EXPERIENCED MODERATE PAIN AND MODERATE TINGLING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149476 UNKNOWN SEAS AUGMENT PROSTHESIS, ELBOW JDB ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other