BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP 52MM O.D. X 46MM I.D.

    MDR report key: 2062639 · Received April 19, 2011

    Report

    Report Number
    1825034-2011-00274
    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 POROUS COATING ON THE CUP APPEARED TO BE INTACT AND SHOWED EVIDENCE OF BONY INGROWTH. ONE SLOT AND ONE OF THE ADJACENT FINS HAD FRACTURED. THIS DAMAGE POSSIBLY OCCURRED DURING SURGICAL REMOVAL OF THE CUP. LIGHT SCRATCHING OF THE BEARING SURFACE WAS OBSERVED BUT 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. THERE WAS EVIDENCE OF DAMAGE AT THE RIM OF THE BEARING SURFACE. IT IS POSSIBLE THAT THIS DAMAGE MIGHT HAVE OCCURRED DUE TO DISLOCATION OR SUBLUXATION OF THE HEAD, OR FROM STEM IMPINGEMENT. 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)(6), 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. (B)(4).

    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 PF CUP 52MM O.D. X 46MM I.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 932920

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R