BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP TIBIAL TRAY-INTERLOK

    MDR report key: 7288757 · Received February 22, 2018

    Report

    Report Number
    0001825034-2018-01256
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    June 26, 2014
    Report Date
    February 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OIY
    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

    ZIMMER BIOMET COMPLAINT: (B)(4). MEDICAL PRODUCT: VANGUARD XP FEMORAL INTERLOK WITH PEGS CATALOG# 195214 LOT# 990240, VANGUARD XP TIBIAL BEARING-LEFT LATERAL CATALOG# 195367 LOT# 677800, VANGUARD XP TIBIAL BEARING-LEFT MEDIAL CATALOG# 195437 LOT# 825590. THE DEVICE WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS OR ANOMALIES. REVIEW OF COMPLAINT HISTORY FOR SAME OR SIMILAR ISSUE IDENTIFIED SEVEN ADDITIONAL COMPLAINTS FOR PART (ITEM) NUMBER AND THREE ADDITIONAL COMPLAINTS WERE IDENTIFIED FOR PART/LOT 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 "MISCELLANEOUS USER NEEDS (GENERAL POST-OPERATIVE PAIN )¿. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01255/01258/01259. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AS PART OF A CLINICAL STUDY THAT A PATIENT UNDERWENT A LEFT KNEE PROCEDURE ON (B)(6) 2014. SUBSQUENTLY, THE PATIENT REPORTED MODERATE PAIN, PROBLEMS WITH WALKING AND PERFORMING DAILY ACTIVITES, OFTEN LIMPING, AND DIFFICULTY USING STAIRS DURING THE SIX (6) MONTH, ONE (1) AND TWO (2) YEAR FOLLOW UP VISITS. IT WAS ALSO REPORTED THAT THE PATIENT WAS STILL USING A CANE 2 YEARS POST IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133736 VANGUARD XP TIBIAL TRAY-INTERLOK PROSTHESIS, KNEE OIY ZIMMER BIOMET, INC. N/A 752560

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R