BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMET REGENX PRI TIB TRAY 75MM

    MDR report key: 17710935 · Received September 8, 2023

    Report

    Report Number
    0001825034-2023-02127
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    March 8, 2016
    Report Date
    November 9, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00880304463585
    PMA / PMN Number
    K080361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: NO COMPLICATION DURING THE PRIMARY SURGERY. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: BIOMET FINNED PRI STEM 40MM: CATALOG#141314, LOT#943170; VNGD PS OPEN POR FMRL LT 70: CATALOG#184532, LOT#427700; E1 VNGD PS TIB BRG 71/75X10: CATALOG#EP-183640, LOT#753860; RGX 3 PEG SER A PATELLA 37MM: CATALOG#141358, LOT#413530. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001825034-2023-02128. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR EVALUATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROGRESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY LEGAL COUNSEL THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, FOUR (4) MONTHS POST-IMPLANTATION, THE TIBIAL COMPONENTS WERE REVISED FOR AN UNKNOWN REASON. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242625 BMET REGENX PRI TIB TRAY 75MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. 970530 00880304463585

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE.