BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TAPER 37/28MM LINER

    MDR report key: 3832340 · Received May 27, 2014

    Report

    Report Number
    0001825034-2014-04777
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    January 27, 2014
    Report Date
    November 10, 2021
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04777 / 04778).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES."

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. THE MODULAR HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. THE MODULAR HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001 AND A RIGHT HIP REVISION ON (B)(6) 2014 DUE TO PAIN AND ELEVATED METAL ION LEVELS. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF CLEAR YELLOW FLUID WITH A BROWNISH DISCOLORATION, BROWNISH DISCOLORATION OF THE SYNOVIUM AND MEMBRANE LINING AND A CENTRAL BONY DEFECT. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED WITH A COMPETITOR'S CUP AND A BIOMET HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311179 M2A TAPER 37/28MM LINER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 452830

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R