BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOACTION

    MDR report key: 1274998 · Received December 23, 2008

    Report

    Report Number
    2027754-2008-00016
    Event Type
    Injury
    Date Received
    December 23, 2008
    Date of Event
    January 1, 2005
    Report Date
    December 18, 2008
    Manufacturer
    OSTEOMED L.P.
    Product Code
    LZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR WAS NOT SURE IF PATIENT WAS COMPLAINT WITH REGARDS TO FOOTWEAR IN THE POSTOP PERIOD. DOCTOR PROMISED TO PROVIDE ADDITIONAL INFORMATION HOWEVER 7 ADDITIONAL REQUESTS FOR INFORMATION OR DETAILS HAVE GONE UNANSWERED. NO LOT NUMBER OR PART NUMBER INFORMATION WAS GIVEN. THIS REPORT IS BASED SOLELY ON DOCTOR'S REPRESENTATION THAT THESE WERE BIOACTION IMPLANTS. THERE IS NO DATA TO CONFIRM OR DENY THE REPRESENTATION. REVIEW OF FIELD EXPERIENCE HISTORY FOR THIS PRODUCT FAMILY DOES NOT REVEAL SIMILAR POSTOPERATIVE COMPLAINT - THIS IS THE ONLY SUCH REPORT. SEPARATION COULD BE CAUSED BY INTRAOPERATIVE DAMAGE SUCH AS GRABBING WITH AN INSTRUMENT. DEPENDING ON DEGREE OF DAMAGE IT MAY HAVE FACILITATED TISSUE INGROWTH, FURTHER SEPARATING THE POLYPROPYLENE INSERT FROM THE METAL IMPLANT. WITHOUT ADDITIONAL INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IN A RECENT CONVERSATION THE SURGEON STATED THAT HE HAD EXPERIENCED TWO CASES IN 2005 OR 2006 WHERE THE POLYPROPYLENE INSERT HAD SEPARATED FROM THE METAL BIOACTION IMPLANT APPROXIMATELY 3-4 MONTHS POST OPERATIVELY. THE PARTS WERE EXPLANTED, DISCARDED, AND REPLACED WITH NEW IMPLANTS. PATIENTS RECOVERED UNEVENTFULLY. THIS HAPPENED SOMETIME IN 2005 OR 2006. COMPANY WAS NOT NOTIFIED AT THAT TIME. DOCTOR WAS NOT SURE IF PATIENT WAS COMPLIANT WITH REGARDS TO FOOTWEAR IN THE POSTOP PERIOD. SEVEN ADDITIONAL REQUESTS FOR INFORMATION OR DETAILS HAVE GONE UNANSWERED. NO LOT NUMBER OR PART NUMBER INFORMATION WAS GIVEN. THIS REPORT IS BASED SOLELY ON DOCTOR'S REPRESENTATION THAT THESE WERE BIOACTION IMPLANTS. THERE IS NOT DATA TO CONFIRM OR DENY THE REPRESENTATION. REVIEW OF FIELD EXPERIENCE HISTORY FOR THIS PRODUCT FAMILY DOES NOT REVEAL SIMILAR POSTOPERATIVE COMPLAINTS - THIS IS THE ONLY SUCH REPORT. SEPARATION COULD BE CAUSE BY INTRAOPERATIVE DAMAGE SUCH AS GRABBING WITH AN INSTRUMENT. DEPENDING ON DEGREE OF DAMAGE IT MAY HAVE FACILITATED TISSUE INGROWTH, FURTHER SEPARATING THE POLYPROPYLENE INSERT FROM THE METAL IMPLANT. WITHOUT ADDITIONAL INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOACTION MPJ IMPLANT LZJ OSTEOMED L.P. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention