BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG LL 9X79

    MDR report key: 7953856 · Received October 10, 2018

    Report

    Report Number
    0001825034-2018-09582
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    October 1, 2015
    Report Date
    March 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 2029046-2019-03108-1 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED PRODUCTS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09582, 0001825034-2018-09583, 0001825034-2018-09584, AND 0001825034-2018-09585. DATE OF BIRTH: UNKNOWN DATE IN (B)(6). (B)(4). CONCOMITANT MEDICAL PRODUCTS: VGXP INTLK FEMORAL LT 70, CATALOG#: 195924, LOT#: 162250; VGXP XP E1 TIB BRG LM 9X79, CATALOG#: 195891, LOT#: 823930; VGXP XP INLK PRI TIB TRAY 79MM CATALOG#: 195758, LOT#: 511500. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT HAD EFFUSION. NO REVISION PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794599 VGXP XP E1 TIB BRG LL 9X79 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 884580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other