BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 3821966 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04412
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    March 20, 2008
    Report Date
    October 31, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." CORRECTED DATA: DATE OF EVENT HAS BEEN CORRECTED IN THIS REPORT. EXPLANT DATE HAS BEEN CORRECTED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    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. 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

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2007 DUE TO PATIENT ALLEGATIONS OF PAIN AND PERSONAL INJURY. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THE SURGERY DATES REPORTED OR WHICH COMPONENTS WERE REMOVED AND REPLACED. HOWEVER, AN INVOICE WAS LOCATED THAT INDICATES A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 WHERE CEMENT SPACER MOLDS WERE IMPLANTED. 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

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2007 DUE TO PATIENT ALLEGATIONS OF PAIN AND PERSONAL INJURY. A REVIEW OF INVOICE HISTORY COULD NOT CONFIRM THE SURGERY DATES REPORTED OR WHICH COMPONENTS WERE REMOVED AND REPLACED. HOWEVER, AN INVOICE WAS LOCATED THAT INDICATES A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 WHERE CEMENT SPACER MOLDS WERE IMPLANTED. 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 DATED (B)(6) 2008 REPORTS PATIENT UNDERWENT AN ACETABULAR REVISION DUE TO PAIN. REVISION OP REPORT NOTES THE PRESENCE OF CLEAR, NON-PURULENT APPEARING JOINT FLUID. OP REPORT FURTHER STATES THE CUP WAS WELL-FIXED AND IN GOOD SHAPE WITHOUT SIGN OF WEAR. THE HEAD WAS REMOVED AND REPLACED. THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR ACETABULAR COMPONENT AND LINER. RECORDS FURTHER REPORT THAT PATIENT UNDERWENT A TWO-STAGE LEFT HIP REVISION PROCEDURE ON (B)(6) 2013 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE PLACED (B)(6) 2013 AND COMPETITOR PRODUCTS WERE IMPLANTED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300190 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 833100

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R