BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS MOD RGX AUG - SM

    MDR report key: 8437339 · Received March 20, 2019

    Report

    Report Number
    0001825034-2019-01215
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 21, 2019
    Report Date
    April 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT BASED ON ADDITIONAL INFORMATION RECEIVED, IT WAS DETERMINED THE EVENT WAS NOT A COMPLAINT. HENCE THE INITIAL REPORT SUBMITTED NEEDS TO BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT BASED ON ADDITIONAL INFORMATION RECEIVED, IT WAS DETERMINED THE EVENT WAS NOT A COMPLAINT. HENCE THE INITIAL REPORT SUBMITTED NEEDS TO BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 211222 COMPR SRS TUMOR BDY - 61MM 538540; 211227 COMPR SRS IC SEG - 120MM 121650; 211230 COMPR SRS MOD STEM - 6X75MM 762960; 211278 COMPR SRS SEAS HMRL HEAD 48X19 241330. FOREIGN - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REMAINS IMPLANTED. 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: 0001825034-2019-01212; 0001825034-2019-01214; 0001825034-2019-01216; 0001825034-2019-01220.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD COMPREHENSIVE SRS HEMIARTHROPLASTY PLACED IN THE RIGHT SHOULDER. SUBSEQUENTLY, THE PATIENT EXPERIENCED WOUND DRAINAGE DURING STAPLE REMOVAL TWO (2) WEEKS POST IMPLANTATION. THE PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228734 COMPR SRS MOD RGX AUG - SM PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 301880

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R