BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD STEM 13MMX115 50% CFE

    MDR report key: 7409663 · Received April 9, 2018

    Report

    Report Number
    0001825034-2018-02420
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 31, 2015
    Report Date
    June 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 113772, BIO-MODULAR HUMERAL HEAD 54DIAX22MM, 842900; EP-115393, E1 44-36 STD HMRL BRNG, 875940; 11-113685, BIO-MOD RVS HMRL A TRAY, 003280; 118001, VERSA-DIAL/COMP TI STD TAPER, 007190; 115310, COMP RVRS SHLDR GLNSP STD 36MM, 996770. CUSTOMER HAS 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 - 2018 - 02419.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF INFORMATION AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMI-SHOULDER ARTHROPLASTY AND WAS REVISED DUE TO UNKNOWN REASONS TO A REVERSE SHOULDER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250677 BIO-MOD STEM 13MMX115 50% CFE PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 891660

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R