BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SCREW RHK KNEE JOINT

    MDR report key: 8891826 · Received August 14, 2019

    Report

    Report Number
    3002806535-2019-00668
    Event Type
    Injury
    Date Received
    August 14, 2019
    Date of Event
    June 22, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: RHK MODULAR TIBIAL 63MM CATALOG #: 154987 LOT #: NOT REPORTED. MEDICAL PRODUCT: RHK 10X80 CEMENTED STEM CATALOG #: 159403 LOT #: NOT REPORTED. MEDICAL PRODUCT: RHK SMALL FEMORAL AUGMENT 20RM CATALOG #: 159454 LOT #: NOT REPORTED. MEDICAL PRODUCT: RHK 63X10 RM/LL STR TIB AUG CATALOG #: 161550 LOT #: NOT REPORTED . MEDICAL PRODUCT: RHK SHORT HINGE ASSEMBLY CATALOG #: 161583 LOT #: NOT REPORTED. MEDICAL PRODUCT: RHK BEARING 12 FOR 63-67TRAY CATALOG #: 159430 LOT #: NOT REPORTED. MEDICAL PRODUCT: BMT SPLINED KNEE STM 12X160 BO CATALOG #: 141872 LOT #: NOT REPORTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 · 0

    IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT A REVISION DUE TO LOOSENING OF THE RHK TIBIAL STEM FIXING SCREW .

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN: EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT A REVISION DUE TO LOOSENING OF THE TIBIAL STEM FIXING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688900 UNK SCREW RHK KNEE JOINT KNEE PROSTHESIS JWH BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R