BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD STD NK

    MDR report key: 3241433 · Received July 22, 2013

    Report

    Report Number
    0001825034-2013-02818
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    November 5, 2012
    Report Date
    March 6, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 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 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02817 / 02818 & 01304).

    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: UNDER POSSIBLE ADVERSE EFFECTS: "FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN COMPONENTS."

    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: UNDER POSSIBLE ADVERSE EFFECTS: "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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY, UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2005. A SUBSEQUENT REVISION OF THE CUP WAS PERFORMED (B)(6) 2012 DUE TO PAIN, ELEVATED METAL ION LEVELS, AND DAMAGE TO SURROUNDING TISSUE AND BONE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2005. A SUBSEQUENT REVISION OF THE CUP WAS PERFORMED (B)(6) 2012 DUE TO PAIN, ELEVATED METAL ION LEVELS, AND DAMAGE TO SURROUNDING TISSUE AND BONE. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS A RIGHT HIP REVISION PROCEDURE WAS DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS, AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2012 DUE TO PAIN AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT NOTED THE PRESENCE OF FLUID, CORROSION AT THE TRUNNION, BLACK DEBRIS, AND A WELL FIXED STEM. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR CUP AND BIOMET HEAD AND TAPER ADAPTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY, UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2005. A SUBSEQUENT REVISION OF THE CUP WAS PERFORMED (B)(6) 2012 DUE TO PAIN, ELEVATED METAL ION LEVELS, AND DAMAGE TO SURROUNDING TISSUE AND BONE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT¿S LEGAL COUNSEL REPORTS A RIGHT HIP REVISION PROCEDURE WAS DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS, AND ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340664 M2A 38MM MODULAR HEAD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 671870

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R