BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 4021545 · Received August 19, 2014

    Report

    Report Number
    0001825034-2014-07179
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    July 14, 2014
    Report Date
    December 2, 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
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. LOT NUMBER IN MEDSUN REPORT NUMBER (B)(4) FILED BY INITIAL REPORTER INCORRECTLY REPORTS LOT NUMBER AS 916550. RECORDS INDICATE THE CORRECT LOT NUMBER IS 915550.

    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 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." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07178 / 07179).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS IT STATES, "MATERIAL SENSITIVITY REACTIONS." . THIS REPORT IS NUMBER 2 OF 4 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07178 /-09190 / -09191).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT¿S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PATIENT¿S ALLEGATIONS OF PAIN AND ELEVATED METAL ION LEVELS. REVIEW OF THE INVOICE HISTORY DOES NOT CONFIRM WHICH SIDE WAS REVISED. HOWEVER, THE INVOICE LOCATED FOR THE RIGHT HIP REVISION PROCEDURE SUGGESTS THAT THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AS THESE ARE THE ARTICULATING SURFACES. 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 THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY (THA) ON (B)(6) 2004 AND A RIGHT THA ON (B)(6) 2008. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PATIENT'S ALLEGATIONS OF PAIN AND ELEVATED METAL ION LEVELS. REVIEW OF THE INVOICE HISTORY DOES NOT CONFIRM WHICH SIDE WAS REVISED. HOWEVER, THE INVOICE LOCATED FOR THE RIGHT HIP REVISION PROCEDURE SUGGESTS THAT THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AS THESE ARE THE ARTICULATING SURFACES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OPERATIVE (OP) NOTES REPORTS PATIENT UNDERWENT A RIGHT THA ON (B)(6) 2008 AND A LEFT THA ON (B)(6) 2004. OP NOTES DATED (B)(6) 2014 FURTHER REPORT PATIENT WAS REVISED ON THE RIGHT HIP DUE TO METAL REACTION, PAIN, MECHANICAL SYMPTOMS, AND ELEVATED METAL ION LEVELS. REVISION OP REPORT NOTES GRAY, CLOUDY SYNOVIAL FLUID CONSISTENT WITH METAL REACTION; BLACK, STAINED SYNOVIUM; METALLOSIS GRANULOMA; AND CYSTIC BONE DESTRUCTION. THE MODULAR HEAD WAS REMOVED AND REPLACED. THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR ACETABULAR COMPONENT. THERE HAS BEEN NO REPORTED REVISION OF THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497094 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 915550

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R