BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 44MM

    MDR report key: 2974292 · Received February 22, 2013

    Report

    Report Number
    0001825034-2013-00324
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    August 9, 2012
    Report Date
    January 27, 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
    OH, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." 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 3 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-00322 / 00326).

    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.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS,TISSUE/BONE DESTRUCTION, PSEUDO TUMOR, PAIN, DISCOMFORT, SWELLING, AND LACK OF MOBILITY. FURTHER, LEGAL COUNSEL FOR THE PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF DISLOCATIONS. A REVIEW OF INVOICE HISTORY CONFIRMS THE SURGERY DATES AND THAT THE CUP, HEAD AND TAPER INSERT WERE REMOVED AND REPLACED ON (B)(6) 2012. INVOICE HISTORY ALSO INDICATES THAT THE MODULAR HEAD AND LINER WERE REPLACED TO A CONSTRAINED SYSTEM DURING THE REVISION ON (B)(6) 2012. NO FURTHER INFORMATION HAS BEEN PROVIDED 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6), 2012 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS, TISSUE/BONE DESTRUCTION, PSEUDO TUMOR, PAIN, DISCOMFORT, SWELLING, AND LACK OF MOBILITY. FURTHER, LEGAL COUNSEL FOR THE PATIENT REPORTS PATIENT WAS REVISED ON (B)(6), 2012 DUE TO PATIENT ALLEGATIONS OF DISLOCATIONS. A REVIEW OF INVOICE HISTORY CONFIRMS THE SURGERY DATES AND THAT THE CUP, HEAD AND TAPER INSERT WERE REMOVED AND REPLACED ON (B)(6), 2012. INVOICE HISTORY ALSO INDICATES THAT THE MODULAR HEAD AND LINER WERE REPLACED TO A CONSTRAINED SYSTEM DURING THE REVISION ON (B)(6), 2012. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT MEDICAL RECORDS INDICATES PATIENT WAS REVISED (B)(6), 2012 DUE TO PAIN AND ELEVATED METAL ION LEVELS. OPERATIVE NOTES REPORT METALLIC STAINING AROUND THE JOINT, EFFUSION WITHIN THE JOINT, JOINT FLUID, AND OSTEOPHYTES WERE OBSERVED. SUBSEQUENTLY, MEDICAL RECORDS INDICATE PATIENT WAS REVISED (B)(6), 2012 DUE TO LEFT HIP DISLOCATIONS. OPERATIVE NOTES REPORT PRESENCE OF JOINT FLUID AND THAT COMPONENTS WERE WELL-POSITIONED AND WELL-FIXED TO THE BONE. OP NOTES ALSO REPORT DEHISCENCE OF THE ABDUCTORS FROM THE MAJORITY OF THE GREATER TROCHANTER, WHICH COULD HAVE CONTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78387 M2A-MAGNUM MODULAR HEAD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 207010

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R