BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM HYBRID COMPREHENSIVE GLENOID BASE 4MM

    MDR report key: 6974353 · Received October 24, 2017

    Report

    Report Number
    0001825034-2017-09610
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    September 1, 2017
    Report Date
    January 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPONENT DID NOT CAUSE SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 118001, VERSA-DIAL/COMPREHENSIVE TI STD TAPER, 116210, 113042, VERSA-DIAL/COMPREHENSIVE 46X18X53 HUMERAL HEAD, 456990, 113628, COMPREHENSIVE PRIMARY STEM 8MM MINI, 890370, PT-113950, COMPREHENSIVE PT HYBRID GLEN POST REGENEREX, 573760. CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 09608. 0001825034 - 2017 - 09609. 0001825034 - 2017 - 09607. 0001825034 - 2017 - 09611.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AND LIMITED RANGE OF MOTION DUE TO RIGHT AXILLARY MONONEUROPATHY AND CARPAL TUNNEL SYNDROME AFTER HAVING SHOULDER ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751852 SM HYBRID COMPREHENSIVE GLENOID BASE 4MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 356750

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O