BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 3970495 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06618
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    February 22, 2013
    Report Date
    April 23, 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
    KS, 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.¿ 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 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06617 & 06618).

    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: "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 1 OF 3 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06617 & 06618 & 1825034-2015-01883).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND INDICATES THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WAS REMOVED AND REPLACED. 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) 2011. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND INDICATES THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED THE REASON FOR REVISION ON (B)(6) 2013 WAS LOOSENING OF ACETABULAR COMPONENT. OPERATIVE REPORT FURTHER NOTED SIGNIFICANT METALLOSIS, LARGE PSEUDOTUMOR, VISIBLE METALLOSIS, NECROTIC TENDERNESS, BONY DEBRIS, SOFT TISSUE EDEMA, AND SCAR TISSUE DURING THE REVISION. THE ACETABULAR CUP WAS REMOVED AND REPLACED BY COMPETITOR PRODUCTS. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2013 DUE TO INFECTION. THE HEAD, CUP, AND LINER WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACERS. OPERATIVE REPORT FURTHER NOTED PATIENT UNDERWENT MULTIPLE PREVIOUS IRRIGATION AND DEBRIDEMENT'S. ADDITIONALLY, PATIENT UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) 2013 DUE TO SWELLING, DISLOCATION OF ANTIBIOTIC SPACERS, AND FORMATION OF ABSCESS. OPERATIVE REPORT FURTHER NOTED LARGE AMOUNT OF REDDISH THICK PURULENT MATERIAL. THE WOUND WENT THROUGH THOROUGH IRRIGATION AND DEBRIDEMENT AND WOUND VAC SPONGES WERE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447686 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 095230

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R