BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD +3MM NK

    MDR report key: 3872745 · Received June 13, 2014

    Report

    Report Number
    0001825034-2014-05470
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    August 18, 2014
    Report Date
    January 21, 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
    TX, 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 OR ASSOCIATED DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, 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.

    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 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05470 /-07601 & 2015-00412 / 00413).

    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: "MATERIAL SENSITIVITY REACTIONS. " THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05470 /-07601).

    Description of Event or Problem · 1

    LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN AND DIFFICULTY WALKING. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM COMPLAINT REPORT NOTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014. THE PRESENCE OF METALLOSIS WAS NOTED DURING THE REVISION PROCEDURE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) REPORT DATED (B)(6) 2014 NOTES THE PRESENCE OF YELLOWISH FIBROUS TISSUE, GRAYISH CAPSULAR TISSUE, CLOUDY FLUID, BLACK RESIDUE ON TAPER OF NECK AND METAL HEAD, SCRATCHES ON THE HEAD, AND CUP OVER-HANG. THE STEM WAS WELL-FIXED. CUP AND HEAD WERE REMOVED AND REPLACED WITH A UNIPOLAR HEAD AS A SPACER. SUBSEQUENTLY, PATIENT UNDERWENT A SECOND REVISION PROCEDURE (B)(6) 2014 DUE TO INFECTION AND RECURRENT DISLOCATIONS. REVISION OP REPORT FURTHER NOTES THAT THE FEMORAL SHAFT FRACTURED BELOW THE TROCHANTERIC OSTEOTOMY THAT WAS PERFORMED TO REMOVE THE WELL-FIXED STEM. THE HEAD AND STEM WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACERS.

    Description of Event or Problem · 1

    LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN AND DIFFICULTY WALKING. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. 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 REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN AND DIFFICULTY WALKING. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM COMPLAINT REPORT NOTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014. THE PRESENCE OF METALLOSIS WAS NOTED DURING THE REVISION PROCEDURE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349037 M2A 38MM MOD HD +3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 949150

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention