BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE GLENOSPHERE

    MDR report key: 7754448 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-06014
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    February 28, 2018
    Report Date
    January 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED BASED ON ADDITIONAL INFORMATION. IT WAS DETERMINED THAT THE PRODUCT DID NOT CONTRIBUTE TO THE REPORTED EVENT.THE INITIAL REPORT SUBMITTED SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000589,  COMP RVRS 25MM BSPLT HA+ADPTR, 592930;  113629, COMP PRIMARY STEM 9MM MINI, 979660; 115370, COMP RVS TRAY CO 44MM, 596600; EP-115393, E1 44-36 STD HMRL BRNG, 734030; 180558, COMP NLK SCR 3.5HEX 4.75X20 ST, 860890; 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, 018440; 115397, COMP RVS CNTRL 6.5X35MM ST/RST, 569900. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 06009; 0001825034 - 2018 - 06025; 0001825034 - 2018 - 06029; 0001825034 - 2018 - 06031.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY, AND WAS REVISED DUE TO UNKNOWN REASONS APPROXIMATELY FIVE (5) MONTHS POST-IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595320 COMPREHENSIVE REVERSE GLENOSPHERE PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 129260

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R