BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 46MM HEAD DIAMETER

    MDR report key: 2062626 · Received April 19, 2011

    Report

    Report Number
    1825034-2011-00275
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2001
    Report Date
    March 22, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 FOURTEEN STATE, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN". THE HEAD AND TAPER ADAPTER WERE STILL ASSEMBLED AND NO ATTEMPT WAS MADE TO SEPARATE THESE COMPONENTS. THE BEARING SURFACE OF THE MODULAR HEAD WAS STAINED WITH DRIED DEPOSITS AND SHOWED FINE SCRATCHES. BANDS OF PARALLEL SCRATCHES WERE ALSO VISIBLE. THESE SCRATCHES ARE POSSIBLE INDICATIONS OF EDGE CONTACT WITH THE RIM OF THE CUP, POSSIBLY FROM SUBLUXATION OR DISLOCATION OF THE HEAD. 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. THE BACK SIDE OF THE MODULAR HEAD SHOWED MINOR DAMAGE, POSSIBLY FROM SURGICAL REMOVAL. THE MODULAR HEAD AND ACETABULAR CUP APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT AND SCRATCHING OF THE BEARING SURFACES. BASED UPON THE APPEARANCE OF THE PARTS, WEAR RATES DID NOT APPEAR TO BE EXCESSIVE. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4) 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED APRIL 19, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. IN (B)(6) 2010 THE PATIENT REPORTED PAIN LOCAL TO RIGHT BUTTOCK AND LATERAL HIP. IN (B)(6) 2010 THE PATIENT REPORTED INTENSE ANTERIOR SLIGHTLY MEDIAL HIP PAIN. A PSOAS TENDON INJECTION WAS PERFORMED UNDER FLUOROSCOPY, WITH NO CHANGE IN STATUS OF THE PATIENT. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011. THE ACETABULAR CUP, MODULAR HEAD, AND TAPER ADAPTER WERE ALL REMOVED AND REPLACED WITH COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD 46MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 827780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R