BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEXION TOE

    MDR report key: 1640215 · Received March 19, 2010

    Report

    Report Number
    2027754-2010-00004
    Event Type
    Injury
    Date Received
    March 19, 2010
    Report Date
    March 19, 2010
    Manufacturer
    OSTEOMED L.P.
    Product Code
    LZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO COMPANY AND IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. DURING PHONE INTERVIEW DOCTOR INDICATED POSSIBLE QUESTIONS PATIENT'S COMPLIANCE. APPARENTLY WENT HOME AND SOAKED THE FOOT IN A PLASTIC GROCERY BAG IN ICE DURING EARLY POST OP PERIOD. CAME TO FIRST POST OP VISIT WITH FOOT WRAPPED IN A PLASTIC BAG. PATIENT INDICATED THAT HE DID A LOT OF WALKING IN EARLY POST OP. IFU CAUTIONS THAT DEVICE IS CONTRAINDICATED IN PATIENTS WHO MAY IGNORE THE LIMITATIONS OF ARTIFICIAL JOINT REPLACEMENT. ALSO, TERRITORY MANAGER REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, INSTRUMENTS WERE DROPPED A COUPLE OF TIMES AND WERE "FLASHED" TO COMPLETE THE CASE. IFU DOES NOT PROVIDE FLASH STERILIZATION INSTRUCTIONS AND WARNS AGAINST STERILIZING ABOVE 275 DEGREES F BECAUSE IT MAY DAMAGE SOME OF THE POLYMERS IN THE INSTRUMENTS.

    Description of Event or Problem · 1

    PATIENT RECEIVED REFLEXION TOE IMPLANT ON (B) (6) 2009. AFTER SURGERY PATIENT HAD SWELLING WITH REDNESS. IN (B) (6), THE PATIENT HAD AN ELEVATED WBC (11,000) WHICH THEN DECLINED. IN (B) (6) PATIENT WAS ADMITTED FOR A POSSIBLE INFECTION WITH WBC BACK AT 11,000, SEVERE REDNESS AND SWELLING. NO FRACTURES WERE PRESENT ON THE X-RAY AND NONE OF THE X-RAYS WERE CONSISTENT WITH OSTEOMYELITIS. DOCTOR PLACED THE PATIENT ON AN IV ANTIBIOTIC. ON (B) (6), 2010 THE IMPLANT WAS REMOVED. DOCTOR STATED THAT HE HAD QUESTIONS ABOUT PATIENT'S POSTOPERATIVE COMPLIANCE/INFECTION CONTROL. DEVICE HISTORY RECORDS SHOWED NO ANOMALIES AND STERILE PROCESSING OF IMPLANTS MET REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEXION TOE GREAT TOE IMPLANT LZJ OSTEOMED L.P. REFLEXION 370-0425 1027462

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALSO OSTEOVATION 390-0005 LOT 09060103 USED DURING| 370-0203 LOT 1027330 (METATARSAL HEAD)| INITIAL IMPLANT.| 370-0225 LOT 1022643 (STEM)