BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X20 ST

    MDR report key: 12540453 · Received September 28, 2021

    Report

    Report Number
    0001825034-2021-02718
    Event Type
    Injury
    Date Received
    September 28, 2021
    Report Date
    November 10, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K130390
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: 0001825034-2021-02715-1. 0001825034-2021-02716-1. 0001825034-2021-02717-1. 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. A POSSIBLE CONTRIBUTING CONDITION TO THE EVENT WAS THE PATIENT'S POOR BONE QUALITY AS NOTED BY THE SALES REP, HOWEVER, THIS WAS UNABLE TO BE CONFIRMED WITH MEDICAL RECORDS. 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 A PATIENT HAS BEEN INDICATED FOR SHOULDER ARTHROPLASTY REVISION DUE TO LOSS OF FIXATION OF THE SCREWS OF THE GLENOID COMPONENT. THIS WAS ATTRIBUTED TO POOR BONE QUALITY AND HIGH ACTIVITY OF THE PATIENT. NO REVISION OR ADDITIONAL PATIENT CONSEQUENCE HAS BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02715, 0001825034-2021-02716, 0001825034-2021-02717. MEDICAL PRODUCTS: ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: 702590, ITEM#: 115397, COMP RVS CNTRL 6.5X35MM ST/RST; LOT#: 898410, ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 740930, ITEM#: 115313, COMP RVSR SHLDR GLNSP +3 36MM; LOT#: 536220, ITEM#: 00434903600, POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER; LOT#: 64410128, ITEM#: 00434903909, HUMERAL STEM SPACER SIZE 9; LOT#: 64227036, ITEM#: 405883, COMP RVS 3.2MM DRL; LOT#: 555880, ITEM#: 405889, COMP RVS 2.7MM DIA DRL; LOT#: 518650. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REQUEST WAS MADE FOR RETURN OF PRODUCT BUT HOSPITAL WOULD NOT RETURN PRODUCT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE DUE TO BONE FRACTURE. THE PATIENT WAS REVISED APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS AGO DUE TO ROTATOR CUFF PATHOLOGY. SUBSEQUENTLY, APPROXIMATELY MORE THAN A ONE (1) YEAR LATER THE IMPLANTS MIGRATED DUE TO THE PATIENT¿S BONE BEING POOR AND IS BEING CONSIDERED FOR ANOTHER REVISION ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441046 COMP LK SCR 3.5HEX 4.75X20 ST SHOULDER PROSTHESIS/EXTREMITIES KWS ZIMMER BIOMET, INC. N/A 791500

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other SEE H10 NARRATIVE