BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 2810051 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02062
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    May 24, 2007
    Report Date
    November 25, 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 THE REASON FOR THE REVISION PROCEDURE, WHICH 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, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-02062-1, 02278-1/02279-1 & 2013-02227).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 5 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02062, 02278 / 02279, 2013-02227 AND 2014-08958).

    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. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02062, 1825034-2012-02278 / 02279).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REVISION HIP ARTHROPLASTY AND FURTHER REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE FOLLOWING: A LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005 AND A RIGHT HIP ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2009. A LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2007 AND A RIGHT HIP REVISION WAS PERFORMED ON (B)(6), 2011. ANOTHER REVISION PROCEDURE TOOK PLACE ON (B)(6), 2012 ON THE RIGHT HIP. THE REASON FOR THE REVISION PROCEDURES WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE RIGHT HIP REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO ACETABULAR CUP LOOSENING, OSTEOLYSIS AND PAIN. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THE LEFT HIP REVISION THAT TOOK PLACE ON (B)(6) 2006 WAS DUE TO DISLOCATION. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. 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 THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REVISION HIP ARTHROPLASTY AND FURTHER REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE FOLLOWING: A LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005 AND A RIGHT HIP ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2009. A LEFT HIP REVISION WAS PERFORMED ON (B)(6), 2007 AND A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2011. ANOTHER REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012, BUT IT IS NOT KNOWN WHETHER IT WAS FOR THE LEFT OR RIGHT HIP. THE REASON FOR THE REVISION PROCEDURES WAS NOT REPORTED. 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 THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REVISION HIP ARTHROPLASTY AND FURTHER REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE FOLLOWING: A LEFT HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005 AND A RIGHT HIP ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2009. A LEFT HIP REVISION WAS PERFORMED ON (B)(6) 2007 AND A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2011. ANOTHER REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012 ON THE RIGHT HIP. THE REASON FOR THE REVISION PROCEDURES WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE RIGHT HIP REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO ACETABULAR CUP LOOSENING, OSTEOLYSIS AND PAIN. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THE LEFT HIP REVISION THAT TOOK PLACE ON (B)(6) 2006 WAS DUE TO DISLOCATION. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED THE PREVIOUSLY REPORTED RIGHT HIP REVISION ON (B)(6) 2011 WAS A LEFT HIP REVISION AND WAS DUE TO DISLODGEMENT OF THE ACETABULAR COMPONENT. THE PATIENT'S OPERATIVE REPORT NOTED A LOOSE ACETABULAR COMPONENT, TWO BROKEN SCREWS, AND FIBROUS TISSUE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED A STAGE 1 LEFT HIP REVISION ON (B)(6) 2007 DUE TO PAIN. THE PATIENT'S OPERATIVE REPORT NOTED EVIDENCE OF REACTIVE SYNOVIUM, NO INGROWTH BEHIND THE ACETABULAR COMPONENT, AND PERIPROSTHETIC INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S PROSTALAC COMPONENTS. FURTHER INFORMATION IN PATIENT MEDICAL RECORDS REVEALED A STAGE 2 LEFT HIP REVISION ON (B)(6) 2007 DUE TO THE TREATMENT OF THE INFECTION WITH RE-IMPLANTATION OF BIOMET COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 550890

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R