BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM MODULAR HEAD TYPE 1 TAPER STANDARD

    MDR report key: 2600057 · Received June 6, 2012

    Report

    Report Number
    0001825034-2012-00797
    Event Type
    Injury
    Date Received
    June 6, 2012
    Date of Event
    February 1, 2011
    Report Date
    May 11, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FORWARDED TO RELAY AN ADDITIONAL MAUDE REPORT WHICH CORRESPONDS TO THE SAME EVENT. MAUDE REPORT (B)(4) WAS FILED ON (B)(4) 2012, AND CORRESPONDS TO THE SAME EVENT. THIS FOLLOW-UP REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00797-1 / 00798-1).

    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 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER FOURTEEN STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN". MAUDE REPORT (B)(4) WAS FILED ON APRIL 26, 2012, AND CORRESPONDS TO THE SAME EVENT. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00797 / 00798).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011, SUBSEQUENTLY, PATIENT EXPERIENCED A DISLOCATION IN THE SAME YEAR, AND WAS HOSPITALIZED FOR THREE DAYS. THE PATIENT ALLEGES SLIPPING, POPPING, BURNING, AND SORENESS IN THE HIP. NO REVISION PROCEDURE HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 36MM MODULAR HEAD TYPE 1 TAPER STANDARD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 047130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R