BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD XP 4IN1 CUT BLOCK ACL PROTECTOR

    MDR report key: 7061214 · Received November 27, 2017

    Report

    Report Number
    0001825034-2017-10388
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    May 20, 2013
    Report Date
    November 17, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    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 INTERLOCK FEMORAL COMPONENT CATALOG# 195203 LOT# 822670; VANGUARD XP TIBIAL TRAY CATALOG# 195246 LOT# 833150; VANGUARD XP TIBIAL BEARING RM CATALOG# 195397 LOT# 883620; VANGUARD TIBIAL BEARING RL CATALOG# 195327 LOT# 908020; BIOMET SERIES A THIN PATELLA CATALOG# 184784 LOT# 976820 THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER PROVIDED. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED FOUR ADDITIONAL COMPLAINTS ASSOCIATED WITH THE PART (CATALOG) NUMBER. WITHOUT AN OPPORTUNITY TO EXAMINE THE INSTRUMENT, THE ROOT CAUSE COULD NOT BE DETERMINED AND THE EVENT COULD NOT BE CONFIRMED. 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, "INCORRECT ASSEMBLE OF/TO MATING INSTRUMENTS¿. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF "GK9C VANGUARD XP EARLY CLINICAL EVALUATION CLINICAL STUDY (B)(6)" A PATIENT WAS IDENTIFIED IN THE STUDY THAT UNDERWENT RIGHT KNEE SURGERY ON (B)(6) 2013 FOR THE PRIMARY DIAGNOSIS OF OSTEOARTHRITIS. IT WAS REPORTED THAT THE ACL PROTECTOR DID NOT ADEQUATELY ASSEMBLE TO AND DISASSEMBLE FROM THE 4 IN 1 CUTTING BLOCK. THE REASON PROVIDED IS UNCLEAR (WE COULDN'T USE BONE WAS IN AT DIDU/OUT). IT WAS NOTED THAT EVEN THOUGH THE ACL PROTECTOR WAS NOT USED, THE ACL WAS FINE. AT THIS TIME 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
    841021 VANGUARD XP 4IN1 CUT BLOCK ACL PROTECTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR