BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP AUG MINI BSPLT W TPR MD

    MDR report key: 9595568 · Received January 16, 2020

    Report

    Report Number
    0001822565-2020-00167
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    August 29, 2019
    Report Date
    February 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K172502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE BASEPLATE WAS REPORTED UNDER THE WRONG MFR NUMBER. THE EVENT WILL BE REPORTED ON 0001825034-2020-00079. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE BASEPLATE WAS REPORTED UNDER THE WRONG MFR NUMBER. THE EVENT WILL BE REPORTED ON 0001825034-2020-00079. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE: PHX. UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP PRIMARY STEM 13MM MINI M MINI CAT# 113633 LOT# 996880, MINI HUMERAL TRAY +5 MM THICKNESS +0 MM TAPER OFFSET 40 MM DIAMETER CAT 110031400 LOT# 64336369, BEARING +3 MM THICKNESS 40 MM DIAMETER CAT# 110031422 LOT# 64291297, GLENOSPHERE STANDARD OFFSET 40 MM DIAMETER CAT# 110030776 LOT# 11024225, COMP RVS CNTRL 6.5X25MM ST/RST CAT# 115395 LOT# 840070, COMP LK SCR 3.5HEX 4.75X15 ST CAT# 180550 LOT# 462580, COMP LK SCR 3.5HEX 4.75X15 ST CAT# 180550 LOT# 206550, COMP LK SCR 3.5HEX 4.75X30 ST CAT# 180553 LOT# 750870, COMP LK SCR 3.5HEX 4.75X30 ST CAT# 180553 LOT# 028290. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE EVENT WAS INITIALLY REPORTED ON 0001825034-2020-00079 UNDER THE WRONG MFR NUMBER. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 00053, 0001822565 - 2020 - 00054, 0001822565 - 2020 - 00055.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY RIGHT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS NOTED TO HAVE AN ASPIRATION OF A HEMATOMA APPROXIMATELY 45 DAYS LATER. THE PATIENT WAS ALSO NOTED TO HAVE HETEROTOPIC OSSIFICATION AT THE 6-MONTH FOLLOW-UP; HOWEVER, NO INTERVENTION WAS NOTED AT THIS TIME AND THE PATIENT CONTINUES TO HAVE IMPROVED OUTCOME MEASURES. 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
    60198 COMP AUG MINI BSPLT W TPR MD PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 64155088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R