BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 50MM HEAD DIAMETER

    MDR report key: 2702798 · Received August 16, 2012

    Report

    Report Number
    0001825034-2012-01304
    Event Type
    Injury
    Date Received
    August 16, 2012
    Date of Event
    October 4, 2012
    Report Date
    March 5, 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
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION AND REVISION DATE, WHICH WERE 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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01301-1 / 01304-1).

    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.

    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: ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿

    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 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01301 / 01304).

    Description of Event or Problem · 1

    PATIENT REPORTED THEY UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGED PAIN, POPPING AND CLICKING SOUNDS, NUMBNESS, ELEVATED COBALT AND CHROMIUM LEVELS, AND NEUROPATHY IN HIS RIGHT SIDE OF HIS BODY, AND NOW HAS A METAL TASTE IS IN HIS MOUTH. DUE TO LEG NUMBNESS, PATIENT ALLEGES FALLS.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, POPPING AND CLICKING SOUNDS, NUMBNESS, ELEVATED COBALT AND CHROMIUM LEVELS, NEUROPATHY ON THE RIGHT SIDE OF HIS BODY. THE PATIENT FURTHER REPORTED TO HAVE A METAL TASTE IN HIS MOUTH AND ALSO ALLEGES TO HAVE FALLEN DUE TO NUMBNESS. LEGAL DOCUMENTS WERE RECEIVED AND REPORT PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, ELEVATED METAL IONS, METALLOSIS, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, AND PERMANENT INSTABILITY AND LOSS OF BALANCE. 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 REPORTED THEY UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT ALLEGES PAIN, POPPING AND CLICKING SOUNDS, NUMBNESS AND NEUROPATHY IN HIS RIGHT SIDE OF HIS BODY, AND NOW HAS A METAL TASTE IS IN HIS MOUTH. DUE TO LEG NUMBNESS, PATIENT ALLEGES FALLS. ONE OF THE FALLS HAS CAUSED MULTIPLE FRACTURES IN HIS ARM. IT IS UNKNOWN WHETHER A REVISION WILL OCCUR.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE TOTAL HIP ARTHROPLASTY ON (B)(6), 2006. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, POPPING AND CLICKING SOUNDS, NUMBNESS, ELEVATED COBALT AND CHROMIUM LEVELS, NEUROPATHY ON THE RIGHT SIDE OF HIS BODY. THE PATIENT FURTHER REPORTED TO HAVE A METAL TASTE IN HIS MOUTH AND ALSO ALLEGES TO HAVE FALLEN DUE TO NUMBNESS. LEGAL DOCUMENTS WERE RECEIVED AND REPORT PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, ELEVATED METAL IONS, METALLOSIS, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, AND PERMANENT INSTABILITY AND LOSS OF BALANCE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. PATIENT OPERATIVE (OP) NOTES REPORT THE PRESENCE OF FLUID. OP NOTES REPORT METALLIC DEBRIS WAS GENERATED DURING THE PROCESS OF REMOVING THE FEMORAL HEAD AND TAPER INSERT FROM THE STEM DUE TO COLD-WELDING. THE HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. THE ACETABULAR COMPONENT WAS REMOVED AND REPLACED WITH A COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD 50MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 786170

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R