BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX52MM CUP

    MDR report key: 3772016 · Received April 25, 2014

    Report

    Report Number
    0001825034-2014-03242
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    January 8, 2014
    Report Date
    April 24, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03241 / 03242).

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2003, AND A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, AND ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE ACETABULAR 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. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT WAS REVISED ON (B)(6) 2014 DUE TO METALLOSIS, SWELLING, PAIN AND WEAKNESS. OPERATIVE REPORT FURTHER NOTED METAL STAINING, OSTEOLYSIS, WALL DEFECTS, FEMORAL LYSIS, ANTEVERSION OF THE ACETABULUM, FLUID AND CORROSION ON THE FEMORAL HEAD. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED AND A LINER WAS IMPLANTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2003, AND A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, AND ELEVATED METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE ACETABULAR 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250933 M2A 38MMX52MM CUP PROSTEHSIS, HIP KWA BIOMET ORTHOPEDICS N/A 527970

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R