BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENOVIS

    MDR report key: 8156224 · Received December 12, 2018

    Report

    Report Number
    3007932279-2018-00002
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    November 2, 2018
    Report Date
    November 19, 2018
    Manufacturer
    RENOVIS SURGICAL TECHNOLOGIES
    Product Code
    OQI
    PMA / PMN Number
    K112897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING RENOVIS IMPLANTS WERE UTILIZED IN THIS SURGERY: · 6.5MM X 30MM, CANCELLOUS BONE SCREW, P/N 1501-865-030, LOT # 10914-1; · 56MM T3 SHELL, CLUSTER HOLE,3/8 DOME HOLE PLUG, P/N 1501-161-056, LOT # 10985-4; · 36MM X 56/58MM UNIVERSAL LINER, HOODED, EMAX, P/N 1527-365-658, LOT # 2178-6; · 36MM, -4MM CERAMIC FEMORAL HEAD, P/N 1451-036-004, LOT # 11233-1; · 13.5MM TAPERED STANDARD OFFSET, P/N 1401-322-135, LOT # 2503-1. RENOVIS IFU 4401-001 LISTS POSSIBLE ADVERSE EFFECTS ASSOCIATED WITH TOTAL HIP ARTHROPLASTY, INCLUDING "EARLY OR LATE POSTOPERATIVE INFECTION." AN INTERNAL REVIEW OF RELATED DEVICE HISTORY RECORDS REVEALED ALL DEVICES MET PRODUCT SPECIFICATIONS, INCLUDING MATERIAL SPECIFICATIONS AND STERILIZATION REQUIREMENTS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), ETC., ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    A REPRESENTATIVE CONTACTED CUSTOMER SERVICE REGARDING AN INSTRUMENT WHICH HAD BROKEN DURING A HIP IMPLANT REVISION SURGERY. UPON FURTHER QUESTIONING, THE REPRESENTATIVE STATED THAT THE IMPLANT WAS EXTRACTED DUE TO PATIENT INFECTION WHICH WAS NOT RESPONDING TO NON-SURGICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993807 RENOVIS TAPERED FEMORAL STEM, STD OFFSET, 13.5MM OQI RENOVIS SURGICAL TECHNOLOGIES A400 2503-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention