BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVSR SHLDR GLNSP +3 36MM

    MDR report key: 11321713 · Received February 12, 2021

    Report

    Report Number
    0001825034-2021-00369
    Event Type
    Injury
    Date Received
    February 12, 2021
    Report Date
    July 7, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304475779
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 115370 UNKNOWN COMP RVS TRAY CO 44MM; XL-115363 792030 ARCOM XL 44-36 STD HMRL BRNG. FOREIGN- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. 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 - 2021 - 00371. DEVICE HAS BEEN DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISLOCATION. THE HUMERAL BEARING, HUMERAL TRAY, AND GLENOSPHERE WERE REMOVED AND REPLACE. THE PATIENT APPEARS TO BE STABLE IN JOINT POST-OPERATIVELY AFTER THE REVISION CASE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220216 COMP RVSR SHLDR GLNSP +3 36MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. 115313 351350 00880304475779

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R