BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 3771210 · Received April 24, 2014

    Report

    Report Number
    0001825034-2014-03170
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    July 12, 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
    NY, 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. IT IS NOT KNOWN IF THIS COMPONENT WAS IMPLANTED IN THE LEFT OR RIGHT HIP AND IT CANNOT BE DETERMINED IF THIS COMPONENT HAS BEEN REMOVED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND 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 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03169 & 03170).

    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. 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: MATERIAL SENSITIVITY REACTIONS. THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03169, 03170, 06350 / 06351).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN. THERE HAS BEEN NO REPORTED REVISION PROCEDURE OF THE LEFT HIP. A REVIEW OF INVOICE HISTORY REVEALED THAT A BILATERAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2009; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION SURGERY AND WHICH COMPONENTS WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE. 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 THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN. THERE HAS BEEN NO REPORTED REVISION PROCEDURE OF THE LEFT HIP. A REVIEW OF INVOICE HISTORY REVEALED THAT A BILATERAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2009; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION SURGERY AND WHICH COMPONENTS WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THE RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2009 AND THE LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2009. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS REVEAL THE RIGHT HIP REVISION PERFORMED ON (B)(6) 2013 WAS DUE TO PAIN, METALLOSIS, FLUID COLLECTION, AND DIFFICULTY OF MOTION. THE PATIENT'S OPERATIVE REPORT NOTED FLUID, AND NECROTIC DARK HEMATOMA. THE HEAD AND CUP WERE REMOVED. THERE IS NO REPORTED REVISION FOR THE LEFT HIP. FURTHER INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS SHOW CORRECT PRODUCT IDENTIFICATION. 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
    250211 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 887410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R