BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM MOD HD STD NECK TP1 TAPER

    MDR report key: 4471451 · Received January 30, 2015

    Report

    Report Number
    0001825034-2015-00418
    Event Type
    Injury
    Date Received
    January 30, 2015
    Report Date
    January 14, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    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. THE PATIENT WAS IMPLANTED WITH BILATERAL HIP ON OCTOBER 22, 1996. IT IS UNKNOWN IF THIS COMPONENT WAS REVISED ON MARCH 5, 2002; THEREFORE, THE FOLLOWING SECTIONS COULD NOT BE COMPLETED AS A RESULT: DATE OF EVENT. DATE IMPLANTED. THIS REPORT IS NUMBER 3 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 (B)(6) 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 (B)(6) 1996. INFORMATION FURTHER REVEALED THAT REVISION PROCEDURES OCCURRED ON THE FOLLOWING DATES DUE TO UNKNOWN REASONS: (B)(6) 2002, (B)(6) 2007, (B)(6) 2013. THERE IS NO FURTHER INFORMATION AVAILABLE FOR THE PROCEDURES LISTED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71289 28MM MOD HD STD NECK TP1 TAPER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 426550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R