BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 3781018 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03422
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    October 24, 2012
    Report Date
    November 6, 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
    AL, 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. 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 "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." 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 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03421/ -03422).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTION: RIGHT TOTAL HIP ARTHROPLASTY DATE HAS BEEN CORRECTED IN THIS REPORT. IMPLANT DATE HAS BEEN CORRECTED IN THIS REPORT.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL FURTHER REPORTED A REVISION PROCEDURE OCCURRED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, METALLOSIS, AND LOSS OF RANGE OF MOTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) NOTES REPORTS PATIENT WAS REVISED DUE TO PAIN AND DISABILITY. REVISION OP REPORT NOTES THE PRESENCE OF CLEAR, YELLOW FLUID; GOOD BONY INGROWTH; AND A POSTERIOR INFERIOR CYST. THE MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. THE CUP WAS REMOVED AND REPLACED WITH COMPETITOR PRODUCTS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL FURTHER REPORTED A REVISION PROCEDURE OCCURRED ON OCTOBER 24, 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, METALLOSIS, AND LOSS OF RANGE OF MOTION. 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
    259739 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 464170

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R