BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DISCOVERY HUMERAL CONDYLE KIT

    MDR report key: 7625803 · Received June 21, 2018

    Report

    Report Number
    0001825034-2018-04195
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    May 5, 2016
    Report Date
    June 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    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'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034-2018-04190, 0001825034-2018-04192, 0001825034-2018-04193, 0001825034-2018-04194, 0001825034-2018-01571, 0001825034-2018-01576, 0001825034-2018-01573, 0001825034-2018-01572, 0001825034-2018-01570, 0001825034-2018-01575. UNKNOWN PART/LOT: BASEPLATE, CENTRAL SCREW, DISCOVERY ULNA, PERIPHERAL SCREWS, DISCOVERY HUMERAL CONDYLE KIT, LONG INTERCALARY SEGMENT, GLENOSPHERE, SHORT INTERCALARY SEGMENT, HUMERAL TRAY, HUMERAL BEARING, 211218 COMPR SRS PROX BDY - LG 42MM; LOT UNKNOWN, 211251 DISTAL HUMERAL BODY, SRS, LOT 706690. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN THE (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. NO MEDICAL RECORDS RECEIVED. X-RAYS WERE SUBMITTED FOR REVIEW. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS GROSSLY APPROPRIATE. NO DEFINITE EVIDENCE FOR LOOSENING OR RADIOLUCENCY. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED POST OPERATIVE PAIN. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466223 UNKNOWN DISCOVERY HUMERAL CONDYLE KIT PROSTHESIS, EXTREMITY HSD ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other