BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLBL UNITE ANT BODY 135 SZ 10

    MDR report key: 7048789 · Received November 21, 2017

    Report

    Report Number
    1818910-2017-29538
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 25, 2017
    Report Date
    October 25, 2017
    Manufacturer
    DEPUY IRELAND 961610 
    Product Code
    HSD
    UDI-DI
    10603295004356
    PMA / PMN Number
    K133834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # PC-(B)(4). INVESTIGATION SUMMARY EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. MANUFACTURING PROCESS ERROR HAS BEEN CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DER STATES THAT A UNITE SZ 10 PROXIMAL BODY WOULD NOT ENGAGE WITH THE SZ 10 STEM DURING THE CASE. IT APPEARED THAT THE SCREW HAD DROPPED OUT OF THE BOTTOM OF THE BODY. WE DID NOT HAVE ANOTHER SZ 10 BODY SO A SZ 8 WAS IMPLANTED. IT WAS ALSO STATED THAT AFTER THE SURGERY WAS OVER AND THE ANATOMIC BODY WAS WASHED, IT WAS DISCOVERED THAT THE SCREW HAD BEEN ASSEMBLED TO THE BODY UPSIDE DOWN. THE HEX HEAD WAS OUT THE BOTTOM OF THE IMPLANT AND IT WAS THREADED UP INTO THE BODY IN REVERSE. IT CAME OUT OF THE STERILE PACKAGING THIS WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829379 GLBL UNITE ANT BODY 135 SZ 10 SHOULDER HUMERAL STEM/EPIPHYSIS HSD DEPUY IRELAND 961610  8556802 10603295004356

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR