BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM COCR MOD HD +6MM NO SKIRT

    MDR report key: 4471456 · Received January 30, 2015

    Report

    Report Number
    0001825034-2015-00419
    Event Type
    Injury
    Date Received
    January 30, 2015
    Date of Event
    May 15, 2007
    Report Date
    January 14, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK974558
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THIS REPORT IS NUMBER 4 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-08497 & 1825034-2015-00417 / 00421).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON OCTOBER 23, 2014 DUE TO POLY WEAR. THE HEAD AND LINER WERE REMOVED AND REPLACED. FURTHER FOLLOW UP FOR INFORMATION AND REVIEW OF INVOICE HISTORY REVEALED THE PATIENT UNDERWENT BILATERAL HIP ARTHROPLASTY ON OCTOBER 22, 1996. INFORMATION FURTHER REVEALED THAT REVISION PROCEDURES OCCURRED ON THE FOLLOWING DATES DUE TO UNKNOWN REASONS: MARCH 5, 2002; OCTOBER 8, 2002; (B)(6) 2007; DECEMBER 18, 2013. THERE IS NO FURTHER INFORMATION AVAILABLE FOR THE PROCEDURES LISTED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70977 28MM COCR MOD HD +6MM NO SKIRT PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 820700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R