BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE REVERSE BASEPLATE

    MDR report key: 6762940 · Received August 3, 2017

    Report

    Report Number
    0001825034-2017-05698
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    January 5, 2017
    Report Date
    October 27, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER: - (B)(6). CONCOMITANT MEDICAL PRODUCT - UNKNOWN BIOMET COMPREHENSIVE SRS PROXIMAL BODY, CAT# NI LOT#: NI. UNKNOWN BIOMET COMPREHENSIVE SRS DISTAL STEM, CAT# NI LOT#: NI. UNKNOWN BIOMET COMPREHENSIVE SRS HUMERAL TRAY, CAT# NI LOT#: NI. UNKNOWN BIOMET COMPREHENSIVE SRS HUMERAL BEARING, CAT# NI LOT#: NI. UNKNOWN BIOMET COMPREHENSIVE SRS GLENOSPHERE, CAT# NI LOT#: NI. PRODUCT IS CURRENTLY NOT EXPECTED TO RETURN TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05664, 0001825034-2017-05694, 0001825034-2017-05695, 0001825034-2017-05696, 0001825034-2017-05697 AND 0001825034-2017-05698.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE IS NOT REPORTABLE AS IT WAS NOT INVOLVED IN THE EVENT AND DID NOT MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT THAT UNDERWENT A SHOULDER ARTHROPLASTY EXPERIENCED PALSY OF THE RADIAL NERVE. THIS WAS REPORTED TO BE NOT A PRODUCT PROBLEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544260 UNKNOWN COMPREHENSIVE REVERSE BASEPLATE PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other