BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP +6 41MM

    MDR report key: 15300042 · Received August 26, 2022

    Report

    Report Number
    0001825034-2022-01920
    Event Type
    Injury
    Date Received
    August 26, 2022
    Report Date
    September 26, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304475816
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-02451. CONCOMITANT MEDICAL PRODUCTS: ITEM#: (B)(4), LOT#: 202960. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01921-1. H6: COMPONENT CODES: MECHANICAL (G04) - HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY FIVE (5) YEARS AND ELEVEN (11) MONTHS LATER THE PATIENT IS PLANNING A FUTURE REVISION SURGERY DUE TO INSTABILITY AND DISLOCATION OF THE IMPLANTS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020071 COMP RVRS SHLDR GLNSP +6 41MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES KWS ZIMMER BIOMET, INC. 115326 741480 00880304475816

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H SEE H10 NARRATIVE