BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 58ODX52ID

    MDR report key: 3961483 · Received July 28, 2014

    Report

    Report Number
    0001825034-2014-06470
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    November 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01831 & 06470).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH AND TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON THE INITIAL REPORT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN."

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. DURING POST OPERATIVE MONITORING AND TESTING, ACETABULAR CUP MALPOSITIONING WAS NOTED. PERI-PROSTHETIC SOFT TISSUE ABNORMALITIES TYPICAL OF A DISEASE OTHER THAN METAL-ON-METAL REACTION INCLUDING INFECTION AND BURSITIS ALSO NOTED. SIMPLE FLUID NOTED IN THE POSTERIOR LATERAL QUADRANT AND INTERIOR LATERAL QUADRANT: 17.4 X 22.1 X 22.4 MM. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING AND PAIN WAS REPORTED BY PATIENT APPROXIMATELY 3 MONTHS POST-OP. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A 522 CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. DURING POST OPERATIVE MONITORING AND TESTING, A MIGRATED ACETABULAR CUP, FLUID, A TENDON TEAR WITH EDEMA AND TROCHANTERIC BURSITIS WERE NOTED. THE FLUID WAS LOCATED IN THE POSTERIOR LATERAL QUADRANT AND INTERIOR LATERAL QUADRANT AND MEASURED 17.4 X 22.1 X 22.4 MM. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438285 M2A-MAGNUM PF CUP 58ODX52ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 739040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention