BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 3181706 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02120
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 25, 2011
    Report Date
    April 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "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 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02119 / 02121).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PATIENT BLOOD TEST RESULTS, WHICH WERE UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-04155 & 02119 / 02121).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS A REVISION PROCEDURE ON (B)(6) 2011, DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, SWELLING, INFLAMMATION, AND DAMAGE TO SURROUNDING BONE/TISSUE. NO FURTHER INFORMATION HAS BEEN PROVIDED 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) 2009. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS A REVISION PROCEDURE ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, SWELLING, INFLAMMATION, AND DAMAGE TO SURROUNDING BONE/TISSUE. INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT UNDERWENT FURTHER REVISION PROCEDURE ON (B)(6) 2012 DUE TO PAIN AND INSTABILITY. THE CUP, HEAD, AND LINER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS A REVISION PROCEDURE ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, SWELLING, INFLAMMATION, AND DAMAGE TO SURROUNDING BONE/TISSUE. INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT UNDERWENT FURTHER REVISION PROCEDURE ON (B)(6) 2012 DUE TO PAIN AND INSTABILITY. THE CUP, HEAD, AND LINER WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THE (B)(6) 2011 REVISION WAS DUE TO PAIN. OPERATIVE NOTES INDICATE FLUID, HYPERTROPHIC SYNOVIAL TISSUE AND NEUTROPHILS AT TIME OF REVISION PROCEDURE. NO METAL STAINING WAS NOTED WITHIN THE HIP. OPERATIVE NOTES INDICATE THE HEAD AND CUP WERE REMOVED AND REPLACED. 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
    283222 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 740290

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R