BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 3190364 · Received June 26, 2013

    Report

    Report Number
    0001825034-2013-02249
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    December 12, 2012
    Report Date
    February 26, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    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 OR DEVIATION. 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 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿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 1 OF 7 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-00926 / 00929 & 1825034-2013-02249 / 02251).

    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. THE ACETABULAR CUP REMAINS IMPLANTED AND WAS NOT REVISED AS PREVIOUSLY REPORTED. CORRECTED DATA: DATE OF EVENT ¿ BLANK ¿ NOT REVISED - REMAINS IMPLANTED. DATE OF EXPLANT ¿ BLANK ¿ NOT REVISED - REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. CORRECTED DATA: EVENT DESCRIPTION - LEFT HIP ARTHROPLASTY TOOK PLACE ON (B)(6) 2009 AND A LEFT HIP REVISION ON (B)(6) 2012.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT FOR LEGAL COUNSEL REPORTS A LEFT HIP REVISION PROCEDURE ON (B)(6) 2012, DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS AND TISSUE/BONE DESTRUCTION. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS AND TISSUE/BONE DESTRUCTION. SUBSEQUENTLY, IT IS ALLEGED PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE (B)(6) 2012 DUE TO PAIN, ELEVATED COCR LEVELS AND TISSUE/BONE DESTRUCTION. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON (B)(6) 2007 AND A RIGHT HIP REVISION ON (B)(6) 2014 DUE TO PAIN. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF HETEROTROPHIC OSSIFICATION AROUND THE TROCHANTER, BLACKENED TISSUE, AND METAL DARKENED TISSUE. THE STEM AND ACETABULAR CUP WERE NOTED TO BE WELL FIXED. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON (B)(6) 2009 AND A RIGHT HIP REVISION ON (B)(6) 2012 DUE TO PAIN. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF CHRONIC LYMPHOCYTIC REACTION INDICATIVE OF INFLAMMATION, SCAR TISSUE, CHRONIC SYNOVITIS, AND NO EVIDENCE OF METALLOSIS. THE STEM AND ACETABULAR CUP WERE NOTED TO BE WELL FIXED. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS AND TISSUE/BONE DESTRUCTION. SUBSEQUENTLY, IT IS ALLEGED PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE (B)(6) 2012 DUE TO PAIN, ELEVATED COCR LEVELS AND TISSUE/BONE DESTRUCTION. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON (B)(6) 2007 AND A RIGHT HIP REVISION ON (B)(6) 2014 DUE TO PAIN. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF HETEROTROPHIC OSSIFICATION AROUND THE TROCHANTER, BLACKENED TISSUE, AND METAL DARKENED TISSUE. THE STEM AND ACETABULAR CUP WERE NOTED TO BE WELL FIXED. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY ON (B)(6) 2009 AND A LEFT HIP REVISION ON (B)(6) 2012 DUE TO PAIN. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF CHRONIC LYMPHOCYTIC REACTION INDICATIVE OF INFLAMMATION, SCAR TISSUE, CHRONIC SYNOVITIS, AND NO EVIDENCE OF METALLOSIS. THE STEM AND ACETABULAR CUP WERE NOTED TO BE WELL FIXED. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290771 M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 094440

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R