BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP FEMORAL INTERLOK-LEFT

    MDR report key: 7121440 · Received December 15, 2017

    Report

    Report Number
    0001825034-2017-10210
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    September 5, 2013
    Report Date
    November 13, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK122160
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: THERAPY DATE: (B)(6) 2013. VANGUARD XP TIBIAL TRAY CATALOG#195249 LOT#313030. VANGUARD XP E1 TIBIAL BEARING LEFT MEDIAL CATALOG#195439 LOT#933920. VANGUARD XP E1 TIBIAL BEARING LEFT LATERAL CATALOG#195369 LOT#910950. BIOMET SERIES A THIN PATELLAR CATALOG#184784 LOT#902120. THE DEVICE WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR DEVIATIONS OR ANOMALIES IDENTIFIED EIGHT DEVIATED PIECES WITH DIMENSIONAL NONCONFORMANCES THAT WERE REWORKED. REVIEW OF COMPLAINT HISTORY FOR SAME ISSUE IDENTIFIED NO ADDITIONAL COMPLAINTS FOR ITEM NUMBER AND NO COMPLAINTS WERE IDENTIFIED FOR ITEM/LOT NUMBER COMBINATION. WITHOUT THE OPPORTUNITY TO EVALUATE THE DEVICE, THE COMPLAINT WAS NOT CONFIRMED AND ROOT CAUSE COULD NOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. ASSOCIATED RISK TABLE LISTS ¿INADEQUATE IMPLANT/ BONE INTERFACE GEOMETRY¿. FOLLOWING REVIEW, NO NEW RISKS WERE IDENTIFIED. 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

    INFORMATION WAS RECEIVED BASED ON REVIEW OF CLINICAL STUDY, (B)(6). A FEMALE PATIENT IN THE STUDY WAS IDENTIFIED THAT UNDERWENT LEFT KNEE SURGERY ON (B)(6) 2013 FOR THE PRIMARY DIAGNOSIS OF OSTEOARTHRITIS. AS PART OF THE STUDY QUESTIONS AND RESPONSES IT WAS NOTED THAT THERE WAS AN IMPINGEMENT ON THE FEMORAL IMPLANT. THE PATIENT OUTCOME IS UNKNOWN AND THERE IS NO INDICATION OF SURGICAL DELAYS OR MEDICAL INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900424 VANGUARD XP FEMORAL INTERLOK-LEFT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 007270

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other