BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDALLION CT 1-PC STM 12X165

    MDR report key: 3107729 · Received May 10, 2013

    Report

    Report Number
    0001825034-2013-01418
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    February 13, 2006
    Report Date
    April 12, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK041850
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. INVOICE HISTORY WAS REVIEWED AND TWO STEMS WERE IMPLANTED FOR THIS PATIENT AND WITH CURRENT INFORMATION PROVIDED, WE CANNOT DETERMINE WHICH STEM WAS REVISED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT BOTH LOTS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." AS IT IS UNKNOWN WHICH HIP WAS REVISED, THE FOLLOWING SECTIONS COULD NOT BE COMPLETED: PRODUCT IDENTIFICATION & EXPIRY DATE. MANUFACTURE DATE - UNKNOWN. ITEM: 71-031612 LOT: 191060; ITEM: 71-031611 LOT: 178980.

    Additional Manufacturer Narrative · 1

    FOLLOW UP REPORT IS BEING SUBMITTED DUE TO RECEIVING PRODUCT IDENTIFICATION INFORMATION AFTER INITIAL REPORT WAS SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY, UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. A SUBSEQUENT REVISION WAS PERFORMED ON (B)(6) 2006 DUE TO A TROCHANTERIC FRACTURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205817 MEDALLION CT 1-PC STM 12X165 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 191060

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R