BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP-XP TIBIAL TRAY-INTERLOK

    MDR report key: 7448869 · Received April 20, 2018

    Report

    Report Number
    0001825034-2018-02906
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    March 5, 2018
    Report Date
    May 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VGXP XP E1 TIB BRG RL 9X63 CATALOG # 195772 LOT # 628340, VGXP XP E1 TIB BRG RM 9X63 CATALOG # 195842 LOT # 940370, VGXP INTLK FMRL RT 62.5 CATALOG # 195204 LOT # 747010, SERIES A PAT STD 34 3 PEG CATALOG # 184766 LOT # 600430. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. REVIEW OF PRIMARY SURGERY OP-NOTES IDENTIFIED NO DEVIATIONS/ COMPLICATIONS DURING THE PROCEDURE. REVIEW OF 3-YEAR FOLLOW-UP NOTES IDENTIFIED PATIENT DEVELOPED LYTIC LESION OF THE RIGHT TIBIA TO LIMITED HER ABILITY TO WALK, ASCEND STAIRS, HAVING SIGNIFICANT PAIN AND BUCKLING OF THE RIGHT KNEE. THE X-RAY REVIEW IDENTIFIED WELL-FIXED FEMORAL, PATELLAR COMPONENTS AND LOOSENING OF THE TIBIAL COMPONENT. REVIEW OF REVISION PROCEDURE OP-NOTES IDENTIFIED A LOOSE TIBIAL COMPONENT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA PROSTHESIS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED PATIENT STARTED EXPERIENCING LYTIC LESION OF THE RIGHT TIBIA, PAIN, AND BUCKLING APPROXIMATELY THREE YEARS POSTIMPLANTATION. THESE ADVERSE EVENTS LIMITED HER ABILITY TO WALK AND ASCEND STAIRS WHILE NOT USING ASSISTIVE DEVICES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291279 VANGUARD XP-XP TIBIAL TRAY-INTERLOK KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 206950

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R