BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 3998651 · Received August 11, 2014

    Report

    Report Number
    0001825034-2014-06986
    Event Type
    Injury
    Date Received
    August 11, 2014
    Report Date
    January 25, 2022
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS." AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04792 /-04793 /-04794 /-06986 /-06987).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION IN THE EVENT DESCRIPTION. 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) 2007 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2009 AND A LEFT HIP REVISION PROCEDURE ON (B)(6) 2014. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED DURING THE LEFT HIP REVISION PROCEDURE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED DURING THE RIGHT HIP REVISION PROCEDURE. 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 HIP REVISION ON (B)(6) 2009 DUE TO A LEG LENGTH DISCREPANCY AND THE PRESENCE OF ADIPOSE TISSUE AND CLEAR JOINT FLUID. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED. AND REPLACED. OPERATIVE REPORT RECEIVED NOTED A LEFT HIP REVISION ON (B)(6) 2014 DUE TO PAIN AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT NOTED THE PRESENCE OF SCAR TISSUE, CLOUDY FLUID CONSISTENT WITH METALLOSIS, NECROSIS AND METALLOSIS. THE MODULAR HEAD WAS REMOVED. AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT BIPOLAR HIP REPLACEMENT SURGERY ON (B)(6) 2007 AND A LEFT TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2009 AND A LEFT HIP REVISION PROCEDURE ON (B)(6) 2014. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED DURING THE LEFT HIP REVISION PROCEDURE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED DURING THE RIGHT HIP REVISION PROCEDURE. 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 HIP REVISION ON (B)(6) 2009 DUE TO A LEG LENGTH DISCREPANCY AND THE PRESENCE OF ADIPOSE TISSUE AND CLEAR JOINT FLUID. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED. AND REPLACED. OPERATIVE REPORT RECEIVED NOTED A LEFT HIP REVISION ON (B)(6) 2014 DUE TO PAIN AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT NOTED THE PRESENCE OF SCAR TISSUE, CLOUDY FLUID CONSISTENT WITH METALLOSIS, NECROSIS AND METALLOSIS. THE MODULAR HEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476453 M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 797500

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization SEE H10 NARRATIVE