BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG RM 10X71

    MDR report key: 4805994 · Received May 29, 2015

    Report

    Report Number
    0001825034-2015-02344
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    May 13, 2015
    Report Date
    November 30, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK122160
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-02345).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: VANGUARD XP RIGHT FEMORAL CAT#: 195203 LOT: 814150; VANGUARD XP TIBIAL TRAY CAT#: 195251 LOT: 764410; SERIES A PATELLA CAT#:184786 LOT: 232350; VANGUARD XP TIBIAL BEARING LATERAL CAT#195333 LOT: 524920. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT HAD A RESECTION OF SCAR TISSUE AND ARTHROTOMY PERFORMED ON (B)(6) 2015. THE TIBIAL BEARINGS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348278 VGXP XP E1 TIB BRG RM 10X71 PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 820160

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R