BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM NON-FLARED ONE-PIECE CUP 38MM X 52MM

    MDR report key: 2060003 · Received April 15, 2011

    Report

    Report Number
    1825034-2011-00278
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: "MATERIAL SENSITIVITY REACTIONS. IMPLANTATION OF FOREIGN MATERIAL IN TISSUES MAY RESULT IN HISTOLOGICAL REACTIONS INVOLVING VARIOUS SIZES OF MACROPHAGES AND FIBROBLASTS. THE CLINICAL SIGNIFICANCE OF THIS EFFECT IS UNCERTAIN, AS SIMILAR CHANGES MAY OCCUR AS A PRECURSOR TO OR DURING THE HEALING PROCESS. PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID. " EVALUATION OF THE RETURNED COMPONENT FOUND THE BEARING SURFACE EXHIBITED WEAR, APPARENTLY DUE TO A THIRD BODY MATERIAL TRAPPED IN THE CLEARANCE. THERE WAS NO EVIDENCE OF CHANGES IN SURFACE CONTOUR AT THE EDGES OF THE CONTACT AREA, FROM WHICH IT IS INFERRED THAT WEAR RATES WERE NOT EXCESSIVE. (B)(4).

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(6), 2011 WITH EVENT DETAILS. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT BOTH THE MANUFACTURER REPORT NUMBER AND ATTACHED USER FACILITY REPORT ARE FOR THE SAME PATIENT, PART NUMBER AND EVENT. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2004. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011. DURING THE REVISION PROCEDURE, THE SURGEON NOTED METAL DEBRIS, CORROSION ON HEAD/NECK TAPER AND PSEUDOTUMOR. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2004. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011. DURING THE REVISION PROCEDURE, THE SURGEON NOTED METAL DEBRIS, CORROSION ON HEAD/NECK TAPER AND PSEUDOTUMOR. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM NON-FLARED ONE-PIECE CUP 38MM X 52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 285870

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R