BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MOD HD 40MM -6

    MDR report key: 3944969 · Received July 18, 2014

    Report

    Report Number
    0001825034-2014-06246
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    July 17, 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
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT REVISION PROCEDURE OCCURRED (B)(6) 2013. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT IDENTIFICATION AND EXPIRATION DATE ¿ NO INFORMATION, 510(K) ¿ NO INFORMATION, MANUFACTURE DATE ¿ NO INFORMATION. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03870 AND -06245 / -06246).

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF INFLAMMATION, COMPLICATIONS WITH HER RIGHT HIP, DISLOCATIONS, PAIN, TROUBLE WALKING, 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 PATIENT OPERATIVE (OP) NOTES REPORTS PATIENT UNDERWENT A TWO STAGE REVISION (B)(6) 2013 DUE TO INFECTION. REVISION OP REPORT DATED (B)(6) 2013 NOTES THE PRESENCE OF BROWN FLUID FROM THE CAPSULE. NOTES ALSO REPORT UNSUCCESSFUL ATTEMPTS TO REMOVE THE FEMORAL HEAD FROM THE TRUNNION AND BONE LOSS OF THE ANTERIOR AND MEDIAL PORTION OF THE PROXIMAL FEMUR. ALL METAL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACERS PLACED DUE TO POTENTIAL FOR INFECTIOUS CHANGES. THERE WAS BONE LOSS AND OSTEOLYSIS ALONG THE POSTERIOR ASPECT OF THE ACETABULUM. OP REPORT DATED (B)(6) 2013 NOTES ANTERIOR BONE LOSS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2013 AND (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF INFLAMMATION, COMPLICATIONS WITH HER RIGHT HIP, DISLOCATIONS, PAIN, TROUBLE WALKING, 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 PATIENT OPERATIVE (OP) NOTES REPORTS PATIENT UNDERWENT A TWO STAGE REVISION (B)(6) 2013 AND (B)(6) 2013 DUE TO INFECTION. REVISION OP REPORT NOTES ALL COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACERS DURING STAGE ONE AND REPLACED DURING STAGE TWO. OP REPORT DATED (B)(6) 2013 NOTES ANTERIOR BONE LOSS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF INFLAMMATION, COMPLICATIONS WITH HER RIGHT HIP, DISLOCATIONS, PAIN, TROUBLE WALKING, AND ELEVATED METAL ION LEVELS. REVIEW OF THE INVOICE HISTORY CONFIRMS THAT AN INITIAL HIP PROCEDURE WAS PERFORMED (B)(6) 2008; HOWEVER, NO RECORDS HAVE BEEN LOCATED TO CONFIRM PROCEDURES ON (B)(6) 2013. THEREFORE, IT COULD NOT BE DETERMINED WHAT COMPONENT(S) MIGHT HAVE BEEN REMOVED OR REPLACED FOR EITHER 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
    421672 SELEX/MAGNUM MOD HD 40MM -6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 484080

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R