BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE ARCOM XL 44-36 STD HUMERAL BEARING

    MDR report key: 7837516 · Received August 31, 2018

    Report

    Report Number
    0001825034-2018-08639
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    May 31, 2018
    Report Date
    October 3, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED. THE COMPLAINT IS CONFIRMED BASED ON THE FOLLOW UP VISIT NOTES THAT WAS PROVIDED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO RELATED DEVIATIONS OR ANOMALIES. A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 115370 COMP RVS TRAY CO 44MM 652170; 115330 COMP RVRS SHDR GLEN BSPLT +HA 786790; 118001 VERSA-DIAL/COMP TI STD TAPER 352400; 115313 COMP RVSR SHLDR GLNSP +3 36MM 142560; 113636 COMP PRIMARY STEM 16MM MINI 614090; 115396 COMP RVS CNTRL 6.5X30MM ST/RST 331330; 180554 COMP LK SCR 3.5HEX 4.75X35 ST 602980; 180550 COMP LK SCR 3.5HEX 4.75X15 ST 410190; 180550 COMP LK SCR 3.5HEX 4.75X15 ST 610760. THE INVESTIGATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08640.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY IN URINATING AFTER CLOSED REDUCTION OF A REVERSE TOTAL SHOULDER PROSTHESIS WAS PERFORMED. PATIENT ¿HAD A LOT OF VISITS TO THE ER¿ FOR IN AND OUT CATHETERS, AND SUBSEQUENTLY DEVELOPED A UTI. PATIENT WAS REFERRED TO A UROLOGIST AND PRESCRIBED MEDICATION FOR TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678167 COMPREHENSIVE REVERSE ARCOM XL 44-36 STD HUMERAL BEARING PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 285250

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R