BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SEAS HEAD

    MDR report key: 7303379 · Received February 28, 2018

    Report

    Report Number
    0001825034-2018-01576
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    May 5, 2016
    Report Date
    June 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    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 · 0

    (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 - 04195; 0001825034 - 2018 - 01571; 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 211218, COMPR SRS PROX BDY - LG 42MM, UNKNOWN, UNKNOWN, UNKNOWN INTERCALARY SEGMENT, UNKNOWN, UNKNOWN, UNKNOWN REGENEREX AUGMENT, UNKNOWN, UNKNOWN, UNKNOWN INTRAMEDULLARY STEM, UNKNOWN, 211251, COMPR SRS 60MM DST HML BDY LT, UNKNOWN, UNKNOWN, UNKNOWN PPS AUGMENT, UNKNOWN, UNKNOWN, UNKNOWN SEAS HEAD, UNKNOWN. 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. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01570, 0001825034 - 2018 - 01571, 0001825034 - 2018 - 01572, 0001825034 - 2018 - 01573, 0001825034 - 2018 - 01574, 0001825034 - 2018 - 01575, 0001825034 - 2018 - 01576. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT ELBOW ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED INABILITY TO OPEN JAR, INABILITY TO DO HEAVY CHORES, INABILITY TO CARRY BAG, INABILITY TO WASH BACK, INABILITY TO CUT, INABILITY TO DO RECREATIONAL ACTIVITIES, INABILITY TO PERFORM SOCIAL ACTIVITIES, MODERATE LIMITATIONS IN DAILY ACTIVITIES, MODERATE PAIN, AND MODERATE DIFFICULTY SLEEPING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146922 UNKNOWN SEAS HEAD ELBOW, PROSTHESIS JDC ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other