BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 3162148 · Received June 11, 2013

    Report

    Report Number
    0001825034-2013-01889
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2010
    Report Date
    May 14, 2013
    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

    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 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 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01889 / 01896).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY REVISION DATES AND THE REASON FOR THE REVISION RECEIVED IN MEDICAL RECORDS, 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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 1 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01889 / 01894).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS, TISSUE/BONE DESTRUCTION, PAIN, SWELLING, INFLAMMATION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, AND LOSS OF RANGE OF MOTION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. 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) 2009 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS, TISSUE/BONE DESTRUCTION, PAIN, SWELLING, INFLAMMATION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, AND LOSS OF RANGE OF MOTION. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT A LEFT HIP REVISION PROCEDURE TOOK PLACE ON (B)(6) 2010 DUE TO CASEOUS FLUID, PAIN AND A METAL ON METAL REACTION. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, TAPER ADAPTER AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS FURTHER INDICATES THAT A RIGHT HIP REVISION PROCEDURE TOOK PLACE ON (B)(6) 2011 DUE TO A FLUID COLLECTION WITH A CASEOUS APPEARANCE. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, TAPER ADAPTER AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262317 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 400370

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R