BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X35 ST

    MDR report key: 19363333 · Received May 21, 2024

    Report

    Report Number
    0001825034-2024-01317
    Event Type
    Injury
    Date Received
    May 21, 2024
    Report Date
    June 6, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677173
    PMA / PMN Number
    K130390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT IS UNKNOWN WHICH SCREW FRACTURED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR AS THE PATIENT WAS LIFTING A HOT WATER HEATER POST-OP. PER IFU, "EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, EXCESSIVE WEIGHT, AND OBESITY HAVE BEEN IMPLICATED WITH PREMATURE FAILURE OF CERTAIN IMPLANTS BY LOOSENING, FRACTURE, DISLOCATION, SUBLUXATION AND/OR WEAR." THE REPORTED EVENT IS CONFIRMED AS THE PATIENT WAS LIFTING A HOT WATER HEATER POST-OP CAUSING THE SCREW TO FRACTURE. 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 · 0

    (B)(4). COMP RVS CNTRL 6.5X30MM ST/RST CAT: 115396 LOT: 036680 COMP LK SCR 3.5HEX 4.75X35 ST CAT: 180554 LOT: 65700031 COMP LK SCR 3.5HEX 4.75X35 ST CAT: 180554 LOT: 161090 COMP LK SCR 3.5HEX 4.75X35 ST CAT: 180554 LOT: 905700 COMP LK SCR 3.5HEX 4.75X20 ST CAT: 180551 LOT: 429670. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO SCREW FRACTURE. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220572 COMP LK SCR 3.5HEX 4.75X35 ST SCREW, FIXATION KWS ZIMMER BIOMET, INC. 760800 00880304677173

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other SEE H10