BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP TIBIAL TRAY

    MDR report key: 7163242 · Received January 4, 2018

    Report

    Report Number
    0001825034-2017-10879
    Event Type
    Injury
    Date Received
    January 4, 2018
    Date of Event
    July 15, 2014
    Report Date
    January 3, 2018
    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)(6). CONCOMITANT: MEDICAL PRODUCT: VANGUARD XP FEMORAL INTERLOK WITH PEGS CATALOG#195203 LOT# 088100; VANGUARD XP TIBIAL BEARING RL CATALOG# 195332 LOT#969820; VANGUARD XP TIBIAL BEARING RM CATALOG# 195402 LOT#946150. 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 FIVE COMPLAINTS FOR PART (ITEM) NUMBER AND NO COMPLAINTS WERE IDENTIFIED FOR LOT NUMBER. NO 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: 0001825034-2017-10877/10880/10883. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE SURGERY ON (B)(6) 2014.SUBSEQUENTLY, THE PATIENT REPORTED PAIN, PROBLEMS WITH DAILY ACTIVITIES, LIMPING, AND NEED FOR SUPPORT DURING THE 3 AND 6 MONTHS, 1 YEAR AND 2 YEAR FOLLOW UP VISITS. DURING THE 3 MONTH FOLLOW UP VISIT ON (B)(6) 2014 THE PATIENT REPORTED PROBLEMS WALKING AROUND, PROBLEMS WASHING/DRESSING SELF, PROBLEMS PERFORMING USUAL ACTIVITIES, SEVERE PAIN, HOUSEBOUND AND NEED OF CRUTCHES FOR SUPPORT. DURING THE 6 MONTH FOLLOW UP VISIT ON (B)(6) 2014 THE PATIENT REPORTED PROBLEMS WALKING, PROBLEMS PERFORMING USUAL ACTIVITIES, MODERATE PAIN, MODERATE TROUBLE WASHING/DRYING SELF, MODERATE TROUBLE GETTING IN OR OUT OF CAR, 5-15 MINUTES OF WALKING BEFORE SEVERE PAIN, VERY PAINFUL TO STAND UP, LIMPING ALL OF TIME, EXTREMELY DIFFICULT TO KNEEL, PAIN HAS GREATLY INTERFERED WITH USUAL WORK, EXTREMELY DIFFICULT TO WALK DOWN STAIRS. DURING THE 1 YEAR FOLLOW UP VISIT ON (B)(6) 2015, THE PATIENT REPORTED MODERATE PAIN, MODERATE TROUBLE WASHING/DRYING SELF, EXTREME TROUBLE GETTING IN OR OUT OF CAR, VERY PAINFUL TO STAND UP, LIMPING ALL OF TIME, EXTREMELY DIFFICULT TO KNEEL, PAIN HAS GREATLY INTERFERED WITH USUAL WORK, OFTEN FELT KNEE MIGHT GIVE WAY. DURING THE 2 YEAR FOLLOW UP VISIT ON (B)(6) 2016 THE PATIENT REPORTED PROBLEMS WALKING, PROBLEMS WASHING/DRESSING SELF, UNABLE TO PERFORM USUAL ACTIVITIES, MODERATE PAIN, MODERATE TROUBLE WASHING/DRYING SELF, EXTREME TROUBLE GETTING IN OR OUT OF CAR, LIMPING ALL OF TIME, IMPOSSIBLE TO KNEEL, PAIN HAS TOTALLY INTERFERED WITH USUAL WORK, MODERATELY DIFFICULT TO DO SHOPPING ON OWN, EXTREMELY DIFFICULT TO WALK DOWN STAIRS. NO FURTHER INFORMATION WAS PROVIDED AND PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7612 VANGUARD XP TIBIAL TRAY KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 881510

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other