BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX48MM

    MDR report key: 3182957 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02155
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 20, 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
    MD, US
    Reporter Occupation
    OTHER

    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, 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 NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02154 / 02155).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY RELEVANT LABORATORY TESTING AND ADDITIONAL INFORMATION SURROUNDING THE REVISION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGED PAIN AND ELEVATED METAL IONS. THE HEAD AND CUP WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD. ADDITIONAL INFORMATION RECEIVED FROM PATIENT¿S LEGAL COUNSEL ALLEGES SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE/TISSUE, AND LACK OF MOBILITY AND RANGE OF MOTION. DURING THE REVISION, METALLOSIS WAS NOTED AROUND THE HIP IMPLANT. 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

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGED PAIN AND ELEVATED METAL IONS. THE HEAD AND CUP WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGED PAIN AND ELEVATED METAL IONS. THE HEAD AND CUP WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL ALLEGES SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE/TISSUE, AND LACK OF MOBILITY AND RANGE OF MOTION. DURING THE REVISION, METALLOSIS WAS NOTED AROUND THE HIP IMPLANT. 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 CONFIRMS THE REASON FOR THE REVISION ON (B)(6) 2013 WAS DUE TO ELEVATED METAL IONS AND PAIN. DURING THE REVISION, SUBSTANTIAL SCAR TISSUE, YELLOW GRAYISH-TINGED FLUID, METALLOSIS COATED ENTIRE INTERNAL ASPECT OF HIP, OSTEOLYSIS, AND MINIMAL INGROWTH ON CUP WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283114 M2A 1 PC SHELL 38MMX48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 540690

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R