BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD -3MM

    MDR report key: 3893961 · Received June 25, 2014

    Report

    Report Number
    0001825034-2014-05733
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    July 24, 2011
    Report Date
    April 29, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. 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.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03789 / 03790 AND 2014-05733 / 05734).

    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. THIS REPORT IS NUMBER 3 OF 8 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03789 / 03790 & 05733 / 05734 & 2015-02003 / 02005 & 02007).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN THE MOM CLINICAL STUDY UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED (B)(6) 2013 DUE TO ALLEGATIONS OF PAIN, DISCOMFORT, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY AND RANGE OF MOTION, DIFFICULTY WALKING, AND ELEVATED METAL ION LEVELS AND METALLOSIS. REVIEW OF INVOICE RECORDS INDICATES THE PATIENT WAS REVISED (B)(6) 2013 AND THE HEAD AND CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION PROVIDED WITH REVIEW OF PATIENT INVOICE RECORDS INDICATE THAT PATIENT HIP REVISION PROCEDURES WERE ALSO PERFORMED ON (B)(6) 2011 AND ON (B)(6) 2011. ADDITIONAL INFORMATION PROVIDED IN PATIENT INVOICE RECORDS INDICATES PATIENT WAS IMPLANTED WITH A HIP MOLD ON (B)(6) 2011. IT IS UNKNOWN WHICH HIP HAD THE ADDITIONAL REVISIONS. 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 PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2011 DUE TO INFECTION. OPERATIVE REPORT FURTHER NOTED PURULENT FLUID AND NECROTIC FAT DURING THE PROCEDURE. ALL COMPONENTS WERE REMOVED AND CEMENT SPACER MOLDS WERE IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2013 DUE TO PAIN. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED AND A LINER WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN THE MOM CLINICAL STUDY UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED (B)(6) 2013 DUE TO ALLEGATIONS OF PAIN, DISCOMFORT, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY AND RANGE OF MOTION, DIFFICULTY WALKING, AND ELEVATED METAL ION LEVELS AND METALLOSIS. REVIEW OF INVOICE RECORDS INDICATES THE PATIENT WAS REVISED (B)(6) 2013 AND THE HEAD AND CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION PROVIDED WITH REVIEW OF PATIENT INVOICE RECORDS INDICATE THAT PATIENT HIP REVISION PROCEDURES WERE ALSO PERFORMED ON (B)(6) 2011 AND ON (B)(6), 2011. ADDITIONAL INFORMATION PROVIDED IN PATIENT INVOICE RECORDS INDICATES PATIENT WAS IMPLANTED WITH A HIP MOLD ON (B)(6) 2011. IT IS UNKNOWN WHICH HIP HAD THE ADDITIONAL REVISIONS. 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
    371302 36MM COCR MOD HD -3MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 710260

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R