BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX58MM CUP

    MDR report key: 3964835 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06533
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    October 18, 2011
    Report Date
    October 27, 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
    NY, 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, ¿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 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06533 AND 06534).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE REFERENCE NUMBERS SHOULD HAVE BEEN LISTED AS (REFERENCE 1825034-2014-06532 & -06533).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, DAMAGE TO BONE/TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2011. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND THAT THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED DURING THE REVISION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT (OP) NOTES REPORTS PATIENT WAS REVISED DUE TO LOOSE ACETABULUM. REVISION OP REPORT NOTES THE CUP MIGRATED LATERALLY, CYSTIC FORMATION, WEAR ON BACK SIDE OF CUP, METALLIC DEBRIS, AND INFLAMMED SYNOVIUM.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, DAMAGE TO BONE/TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2011. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND THAT THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED DURING THE REVISION. 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
    441864 M2A 38MMX58MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 047980

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R