BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HEAD+6MM NK NO SKRT

    MDR report key: 3810232 · Received May 14, 2014

    Report

    Report Number
    0001825034-2014-03972
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    June 9, 2014
    Report Date
    December 12, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 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, ¿POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03971 / 03972).

    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

    THIS FOLLOW-UP IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT'S ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, PSEUDOTUMORS, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, ELEVATED METAL ION LEVELS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING AND METALLOSIS. THERE HAS BEEN NO REPORTED REVISION 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

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT'S ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, PSEUDOTUMORS, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, ELEVATED METAL ION LEVELS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING AND METALLOSIS. REVIEW OF THE INVOICE RECORD INDICATES THE PATIENT WAS REVISED (B)(6) 2014. THE CUP 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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT'S ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, PSEUDOTUMORS, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, ELEVATED METAL ION LEVELS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING AND METALLOSIS. THERE HAS BEEN NO REPORTED REVISION TO DATE. 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 REVEALED A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO SUSPECT ALVAL. THE PATIENT'S OPERATIVE REPORT NOTED YELLOW DISCOLORATION TISSUE MEMBRANE, AND THE TRUNNION HAD OXIDATION CORROSION. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED PATIENT'S BLOOD WAS TESTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288866 M2A 38MM MOD HEAD+6MM NK NO SKRT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 093620

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Congenital Anomaly| H