BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX52MM CUP

    MDR report key: 3833780 · Received May 27, 2014

    Report

    Report Number
    0001825034-2014-04814
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    March 4, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THIS REPORT IS NUMBER 2 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04813 / 04816 & 2015-01053

    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, 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 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04813 / 04816).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013. ALL COMPONENTS WERE 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 OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013 DUE TO PAIN, DIFFICULTY WALKING AND A PERIPROSTHETIC FRACTURE. OPERATIVE REPORT FURTHER NOTED METALLOSIS, LYTIC DEBRIS, OSTEOLYSIS, CORROSION, SOFT TISSUE DEBRIS AND BONE LOSS DURING THE REVISION PROCEDURE. ALL COMPONENTS WERE REMOVED AND REPLACED AND CABLES WERE IMPLANTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE HAS BEEN NO REPORTED LEFT HIP REVISION PROCEDURE TO DATE. 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
    310414 M2A 38MMX52MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 527940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention