BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP +6 36MM

    MDR report key: 8155453 · Received December 12, 2018

    Report

    Report Number
    0001825034-2018-11140
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    May 14, 2018
    Report Date
    April 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE HAS PREVIOUSLY BEEN REPORTED FOR THIS EVENT ON REPORT NUMBER 0001825034-2017-11268. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT MEDICAL PRODUCTS: XL-115365, ARCOM XL 44-36 RTNV+3 HMRL BRG, LOT 418890, 115378, COMP RVS TRAY +10MM CO 44MM, LOT 975780, 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT 161050, 115400, COMP RVS CNTRL 6.5X50MM ST/RST, 336510, 180561, COMP NLK SCR 3.5HEX 4.75X35 ST, LOT 533210, 180562, COMP NLK SCR 3.5HEX 4.75X40 ST, LOT 849740, 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, LOT 251780, 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, LOT 480010, 180563, COMP NLK SCR 3.5HEX 4.75X45 ST, LOT 454650, 211230, COMPR SRS MOD STEM - 6X75MM, LOT 541500, 211216, COMPR SRS PROX BDY - SM 58MM, LOT 688930. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 11141, 0001825034 - 2018 - 11142.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS POST IMPLANTATION, PATIENT UNDERWENT A REVISION OF THE GLENOSPHERE, BEARING, AND TRAY DUE TO DISLOCATIONS. PATIENT WAS CONVERTED TO A CUSTOM CONSTRAINED DEVICE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997123 COMP RVRS SHLDR GLNSP +6 36MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 693250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R