BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SESAMOID PLASTY CAMERA KIT - P7

    MDR report key: 6984137 · Received October 27, 2017

    Report

    Report Number
    0009617840-2017-00025
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    September 19, 2017
    Report Date
    February 2, 2018
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    PK110054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE ACCURACY OF THE CAMERA WAS VERIFIED LOCALLY BY A ZIMMER BIOMET AUSTRALIA REPAIR TECHNICIAN. NO PROBLEMS WERE FOUND WITH THE CAMERA. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INITIAL MEDWATCH WAS SUBMITTED WITH A NOTIFICATION DATE OF OCT 5, 2017 AND SUBMITTED ON OCT 27, 2017; HOWEVER THE CORRECT NOTIFICATION DATE IS SEP 19, 2017.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE SURGICAL SYSTEM SHOWED THE PATIENT'S KNEE TO HAVE PREVIOUS VARUS DEFORMITY CORRECTED AND KNEE WAS "STRAIGHT". HOWEVER, POST-OPERATIVE X-RAYS SHOWED THE KNEE TO THEN BE IN VALGUS. NO INTERVENTION OR PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764005 SESAMOID PLASTY CAMERA KIT - P7 STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A P7-01759

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN KNEE IMPLANT