BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SMOOTH KNEE STEMS 16X40

    MDR report key: 6301739 · Received February 3, 2017

    Report

    Report Number
    0001825034-2017-00395
    Event Type
    Injury
    Date Received
    February 3, 2017
    Report Date
    June 30, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). CONCOMITANT PRODUCTS: SPLINED KNEE STEM / PN 141618/ LN 883600. VANGUARD SSK / PN 185282/ LN 2597034. SERIES A STANDARD PATELLA / PN 184762/ LN 007230. TIBIAL SM CRUCIATE WING / PN 185650/ LN 056270. TIBIAL OFFSET ADAPTER / PN 185211/ LN 154920. TIBIAL TRAY / PN 185202/ LN 914440. THIS REPORT IS NUMBER 2 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2017-00393, 0001825034-2017-00396, 0001825034-2017-00399, 0001825034-2017-00406, 0001825034-2017-00407, 0001825034-2017-00408).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

    THE PATIENT UNDERWENT A REVISION SURGERY, BUT IT WAS REPORTED THAT THE SAME ¿DARK SPOT¿ APPEARED AFTER A SHORT PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82802 BIOMET SMOOTH KNEE STEMS 16X40 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 035600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other