BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX64 MM CUP

    MDR report key: 3822045 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04455
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    July 9, 2012
    Report Date
    July 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04455 / 04457 AND 07085 / 07086).

    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 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ 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 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04455/04457).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO BONE/TISSUE, LACK OF MOBILITY AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, LEGAL COUNSEL REPORTS PATIENT UNDERWENT REVISION PROCEDURES IN 2007, (B)(6) 2013, (B)(6) 2013 AND (B)(6) 2014. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, REVISION INVOICES LOCATED INDICATE PATIENT UNDERWENT REVISION PROCEDURE ON (B)(6) 2010 AND (B)(6) 2014. DURING THE REVISION PROCEDURES, THE MODULAR HEADS, TAPER ADAPTERS AND ACETABULAR COMPONENTS 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 PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO BONE/TISSUE, LACK OF MOBILITY AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, LEGAL COUNSEL REPORTS PATIENT UNDERWENT REVISION PROCEDURES IN 2007. (B)(6) 2013, (B)(6) 2013 AND (B)(6) 2014. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, REVISION INVOICES LOCATED INDICATE PATIENT UNDERWENT REVISION PROCEDURE ON (B)(6) 2010 AND (B)(6) 2014. DURING THE REVISION PROCEDURES, THE MODULAR HEADS, TAPER ADAPTERS AND ACETABULAR COMPONENTS 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 INDICATES PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT LEFT HIP REVISION PERFORMED ON (B)(6) 2012 WAS DUE TO SEROMA AND SWELLING. THE PATIENT'S OPERATIVE REPORT NOTED FLUID. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT LEFT HIP REVISION PERFORMED ON (B)(6) 2013 WAS DUE TO PERIPROSTHETIC FEMUR FRACTURE. THE PATIENT'S OPERATIVE REPORT NOTED A LOOSE STEM. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT LEFT HIP REVISION PERFORMED ON (B)(6) 2013 WAS DUE TO A FRACTURED TAPER. THE PATIENT'S OPERATIVE REPORT NOTED BROKEN STEM AND METAL DEBRIS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT LEFT HIP REVISION PERFORMED ON (B)(6) 2014 WAS DUE TO AN UNSTABLE HIP AND DISLOCATIONS. THE PATIENT'S OPERATIVE REPORT NOTED LOOSE CABLES. FURTHER INFORMATION IN PATIENT MEDICAL RECORDS NOTED COMPETITOR COMPONENTS IMPLANTED ON (B)(6) 2013 AND (B)(6) 2013. THERE HAS BEEN NO REPORTED REVISION FOR THE RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299765 M2A 38MMX64 MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 195630

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R