BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD +3 HMRL BRG

    MDR report key: 6882998 · Received September 21, 2017

    Report

    Report Number
    0001825034-2017-07201
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    June 8, 2017
    Report Date
    January 31, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: COMP RVSR SHLDR GLNSP +3 36MM, CAT: 115313, LOT: 434000; COMP PRIMARY STEM 6 X 194 REV, CAT: 113666, LOT: 503390; COMP. REV SHLDR 9 IN STEINMANN, CAT: 405800, LOT: 930600; COMP RVS TRAY +10MM CO 44MM, CAT: 115378, LOT: 621420; COMP LK SCR 3.5HEX 4.75X20 ST, CAT: 180551, LOT: 196430; COMP LK SCR 3.5HEX 4.75X20 ST, CAT: 180551, LOT: 488590; VERSA-DIAL TAPER ADAPTOR 25MM, CAT: 110031378, LOT: 716090; COMPR VRS GLEN PPS MIN TPR ADR, CAT: 110027734, LOT: 716060; COMP LK SCR 3.5HEX 4.75X30 ST, CAT: 180553, LOT: 333540; COMP LK SCR 3.5HEX 4.75X35 ST, CAT: 180554, LOT: 095420; COMP RVS CNTRL 6.5X35MM ST/RST, CAT: 115397, LOT: 927940. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO A LOOSE JOINT/DISLOCATION. LOSS OF ROTATOR CUFF AND SOFT TISSUE WERE IDENTIFIED AS CONTRIBUTING CONDITIONS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663877 ARCOM XL 44-36 STD +3 HMRL BRG PROSTHESIS, EXTREMITY PAO ZIMMER BIOMET, INC. N/A 636530

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R