BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE ARCOM XL 44-36 STD HUMERAL BEARING

    MDR report key: 7837444 · Received August 31, 2018

    Report

    Report Number
    0001825034-2018-08513
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    May 31, 2018
    Report Date
    August 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 REPORTED EVENT CAN BE CONFIRMED BASED ON THE X-RAYS PROVIDED. X-RAY REVIEW SHOWS SUPERIOR DISLOCATION IS CONFIRMED. THERE IS NO FRACTURE SEEN BUT THE GLENOSPHERE APPEARED TO BE SOMEWHAT INFERIORLY POSITIONED. WITHOUT PRE-DISLOCATION X-RAYS IT CANNOT BE DETERMINED WHAT THE POSITION OF THE DEVICES WERE WHEN FIRST IMPLANTED; THEREFORE, IT CANNOT BE CONCLUDED IF THE GLENOSPHERE/TAPER HAS SPUN IN THE BASEPLATE OR IF THE POSITIONING WAS INTENTIONALLY INFERIOR DUE TO THE OFFSET OF THE TAPER ADAPTER WHICH WOULD HAVE BEEN CHOSEN DURING TRIALING OF COMPONENTS IN THE INITIAL PROCEDURE. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO RELATED DEVIATIONS OR ANOMALIES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08636.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT REVERSE SHOULDER ARTHROPLASTY REVISION DUE TO RECURRENT DISLOCATION OF THE RIGHT SHOULDER. THE PATIENT WAS ADDITIONALLY EXPERIENCING PAIN, CLICKING, AND INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680293 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