BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS MODULAR REVISION SYSTEM CONE PROXIMAL BODY TYPE 1 TAPER

    MDR report key: 6350499 · Received February 22, 2017

    Report

    Report Number
    0001825034-2017-00858
    Event Type
    Injury
    Date Received
    February 22, 2017
    Report Date
    October 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - G7 SCREW CATALOG#: 010000999 LOT#: 3782400, G7 OSSEOTI SHELL CATALOG#: 110010267 LOT#: R3618029A, G7 DUAL MOBILITY LINER CATALOG#: 110024465 LOT#: 719520, ARCOS DISTAL STEM CATALOG#: 11-300816 LOT#: 913480, CERAMIC FEMORAL HEAD CATALOG#: 650-1055 LOT#: 005680, CERAMIC TAPER SLEEVE CATALOG#: 650-1066 LOT#: 215630, ACTIVE ARTICULATION BEARING CATALOG#: EP-200152 LOT#: 281510. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(6). BLOOD TESTS PERFORMED (B)(6) 2016 REVEALED CHROMIUM LEVEL OF 4.3 UG/L 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR. UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION."

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT HAS BEEN INDICATED FOR REVISION DUE TO ALLEGATIONS OF INFECTION. NO REVISION HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132811 ARCOS MODULAR REVISION SYSTEM CONE PROXIMAL BODY TYPE 1 TAPER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 763340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other