BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 2923232 · Received January 18, 2013

    Report

    Report Number
    0001825034-2013-00139
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 13, 2012
    Report Date
    August 25, 2022
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - BILATERAL REVISION DATES, (B)(6) 2012. IT IS UNKNOWN WHICH DATE CORRESPONDS TO WHICH SIDE. DATE EXPLANTED - BILATERAL REVISION DATES, (B)(6) 2012. IT IS UNKNOWN WHICH DATE CORRESPONDS TO WHICH SIDE. THIS REPORT IS NUMBER 9 OF 9 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02070 / 02072, 02070-1 / 02072-1, 1825034-2013-00137 / 00139). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    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: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-02070/-02071/-02072 & 2013-00137/-00138/-00139).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE BILATERAL TOTAL HIP ARTHROPLASTY AND ALLEGES PAIN AND POSSIBLE ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED THAT PATIENT UNDERWENT INITIAL TOTAL HIP ARTHROPLASTY PROCEDURES ON (B)(6) 2009 AND (B)(6) 2010. IT IS UNKNOWN WHICH SIDE WAS IMPLANTED ON EACH INITIAL PROCEDURE DATE. FOLLOW UP WITH THE PATIENT'S PHYSICIAN OFFICE VERIFIED PATIENT'S ALLEGATION OF ELEVATED COBALT AND CHROMIUM LEVELS. SUBSEQUENTLY, REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2012. IT IS UNKNOWN WHICH SIDE WAS REVISED ON EACH REVISION DATE.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE BILATERAL TOTAL HIP ARTHROPLASTY AND ALLEGES PAIN AND POSSIBLE ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED THAT PATIENT UNDERWENT INITIAL TOTAL HIP ARTHROPLASTY PROCEDURES ON (B)(6), 2009 AND (B)(6), 2010. IT IS UNKNOWN WHICH SIDE WAS IMPLANTED ON EACH INITIAL PROCEDURE DATE. FOLLOW UP WITH THE PATIENT'S PHYSICIAN OFFICE VERIFIED PATIENT'S ALLEGATION OF ELEVATED COBALT AND CHROMIUM LEVELS. SUBSEQUENTLY, REVISION PROCEDURES WERE PERFORMED ON (B)(6), 2012. IT IS UNKNOWN WHICH SIDE WAS REVISED ON EACH REVISION DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2009 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6), 2012 AND A LEFT HIP REVISION ON (B)(6), 2012 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN, AGGRAVATION OF PATIENT'S PARKINSON DISEASE, TISSUE AND BONE DESTRUCTION, METALLOSIS. LEGAL COUNSEL FURTHER ALLEGES THAT METAL DEBRIS, METAL STAINING, SYNOVITIS, DAMAGED SYNOVIUM, HISTIOCYTIC INFLAMMATORY REACTION WERE NOTED DURING THE LEFT HIP REVISION PROCEDURE AND THE PRESENCE OF MURKY YELLOW FLUID AND METAL STAINING WERE NOTED DURING THE RIGHT HIP REVISION PROCEDURE.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE BILATERAL TOTAL HIP ARTHROPLASTY AND ALLEGES PAIN AND POSSIBLE ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED THAT PATIENT UNDERWENT INITIAL TOTAL HIP ARTHROPLASTY PROCEDURES ON (B)(6) 2009 AND (B)(6) 2010. IT IS UNKNOWN WHICH SIDE WAS IMPLANTED ON EACH INITIAL PROCEDURE DATE. FOLLOW UP WITH THE PATIENT'S PHYSICIAN OFFICE VERIFIED PATIENT'S ALLEGATION OF ELEVATED COBALT AND CHROMIUM LEVELS. SUBSEQUENTLY, REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2012. IT IS UNKNOWN WHICH SIDE WAS REVISED ON EACH REVISION DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2012 AND A LEFT HIP REVISION ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN, AGGRAVATION OF PATIENT'S PARKINSON DISEASE, TISSUE AND BONE DESTRUCTION, METALLOSIS. LEGAL COUNSEL FURTHER ALLEGES THAT METAL DEBRIS, METAL STAINING, SYNOVITIS, DAMAGED SYNOVIUM, HISTIOCYTIC INFLAMMATORY REACTION WERE NOTED DURING THE LEFT HIP REVISION PROCEDURE AND THE PRESENCE OF MURKY YELLOW FLUID AND METAL STAINING WERE NOTED DURING THE RIGHT HIP REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL THE LEFT HIP REVISION ON (B)(6) 2012 WAS DUE TO PAIN AND ELEVATED METAL ION LEVELS. THE PATIENT'S OPERATIVE REPORT NOTED METAL DEBRIS IN SOFT TISSUES, FLUID, METAL STAINING, AND SYNOVITIS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL THE RIGHT HIP REVISION ON (B)(6) 2012 WAS DUE TO PAIN AND METALLOSIS. THE PATIENT'S OPERATIVE REPORT NOTED MURKY YELLOW FLUID AND METAL STAINING. FURTHER INFORMATION IN PATIENT MEDICAL RECORDS REVEAL PATIENT'S BLOOD WAS TESTED ON (B)(6) 2012, AND (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27264 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 520360

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Hospitalization| R