BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC MOD TIB I DCM BRNG 16X75

    MDR report key: 8087054 · Received November 19, 2018

    Report

    Report Number
    0001825034-2018-10813
    Event Type
    Injury
    Date Received
    November 19, 2018
    Report Date
    August 8, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K912245
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. X-RAY EVALUATION PERFORMED BY THIRD PARTY HCP STATES THAT THERE IS POSSIBLE POLYETHYLENE WEAR OF THE LATERAL COMPARTMENT. THE LATERAL MOST SCREW WITHIN THE MEDIAL COMPARTMENT OF THE TIBIAL COMPONENT IS NOT FLUSH WITH THE PLATE, OF UNCERTAIN CLINICAL SIGNIFICANCE. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE REPORTED COMPONENTS ARE NOT COMPATIBLE WITH EACH OTHER; HOWEVER, IT IS UNKNOWN IF THE REPORTED PART NUMBERS ARE WHAT IS EVEN IMPLANTED. A DEFINITIVE ROOT CAUSE CANNOT 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: AGC MOD TIB II POR PLATE 75, CAT#: 155594, LOT#: UNK; AGC TRAD PRI TIB BEAR 10X71/75, CAT#: 151010, LOT#: UNK. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2018-10811, 0001825034-2018-10813, 0001825034-2018-10814. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923756 AGC MOD TIB I DCM BRNG 16X75 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R