BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 56MM

    MDR report key: 3801015 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03735
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 16, 2009
    Report Date
    June 3, 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
    PA, 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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "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 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03734/ -03735).

    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 2 OF 3 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03734/ -03735 AND -05446).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FURTHER REPORTS A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND ELEVATED METAL ION LEVELS. 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 THE PATIENT ALLEGES THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FURTHER REPORTS A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OPERATIVE (OP) NOTES REPORTS THE PATIENT WAS REVISED DUE TO PAIN. OP NOTES DATED (B)(6) 2014 REPORT THE PRESENCE OF HETEROTOPIC OSSIFICATION BUT NO EVIDENCE OF METALLOSIS OR BURNISHING OF FEMORAL HEAD WAS OBSERVED. OP NOTES FURTHER REPORT THE TAPER ADAPTER WOULD NOT DISENGAGE FROM THE STEM AND THE REVISION WAS POSTPONED. REVISION OP NOTES DATED (B)(6) 2014 REPORTS THE TAPER ADAPTER WAS FOUND TO BE FUSED TO THE STEM, BUT REMOVABLE. THE HEAD AND TAPER WERE REMOVED AND REPLACED. THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277802 M2A-MAGNUM MOD HD SZ 56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 255140

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R