BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 7X26MM IMPL STEM W/SCR

    MDR report key: 12197690 · Received July 20, 2021

    Report

    Report Number
    0001825034-2021-02156
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    June 29, 2021
    Report Date
    November 2, 2021
    Product Code
    KWI
    PMA / PMN Number
    K040611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THERE ARE SOME DINGS ON THE STEM AND THE POROUS COAT. THE SCREW HAS SOME DAMAGE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN: (B)(6). CONCOMITANT PRODUCTS: EXPLOR 10X24 MM IMPLANT HEAD CAT: 11-210041 LOT: 899800. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO LOOSENING. THE IMPLANT WAS REMOVED. THE HOSPITAL DID NOT HAVE AN IMPLANT AVAILABLE TO REPLACE IT. NO FURTHER MEDICAL INTERVENTION HAS BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092822 EXPLOR 7X26MM IMPL STEM W/SCR ELBOW, PROSTHESIS KWI 044260

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10