BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ROM*ADAPTOR HUDSON TO ZIMMER

    MDR report key: 7077927 · Received December 2, 2017

    Report

    Report Number
    1818910-2017-50620
    Event Type
    Malfunction
    Date Received
    December 2, 2017
    Date of Event
    November 6, 2017
    Report Date
    November 6, 2017
    Manufacturer
    DEPUY IRELAND 961610 
    Product Code
    HWE
    UDI-DI
    10603295171539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). INVESTIGATION SUMMARY:EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. 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

    PRODUCT COMPLAINT: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. 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

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEPUY HUDSON TO ZIMMER CHUCK ADAPTER CRACKED AROUND FEMALE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856838 S-ROM*ADAPTOR HUDSON TO ZIMMER HIP TRIAL/INSTRUMENT HWE DEPUY IRELAND 961610  A0805 10603295171539

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR