BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - KITS/SETS: FNS IMPLANT KIT

    MDR report key: 14278170 · Received May 4, 2022

    Report

    Report Number
    8030965-2022-02885
    Event Type
    Injury
    Date Received
    May 4, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K: THIS REPORT IS FOR AN UNKNOWN KITS/SETS: FNS IMPLANT KIT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: STASSENN R, ET AL. (2021), FIRST CLINICAL RESULTS OF 1 YEAR FOLLOW UP OF THE FEMORAL NECK SYSTEM FOR INTERNAL FIXATION OF FEMORAL NECK FRACTURES, ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, HTTPS://DOI.ORG/10.1007/S00402-021-04216-0. (NETHERLANDS). THE OBJECTIVE OF THIS STUDY IS TO PROVIDE OUR FIRST YEAR OF CLINICAL EXPERIENCE USING FEMORAL NECK SYSTEM AT A LARGE LEVEL II TRAUMA TEACHING HOSPITAL, WITH A SPECIAL FOCUS ON IMPLANT FAILURE IN PERSPECTIVE TO COMMONLY KNOWN RISK FACTORS. DURING THE PERIOD OF NOVEMBER 2018¿NOVEMBER 2019, 34 PATIENTS TREATED WITH FEMORAL NECK SYSTEM WERE INCLUDED IN THIS STUDY. THERE WERE 14 MALES AND 20 FEMALES WITH A MEAN AGE OF 63 YEARS (RANGE 59.6-65.5). ALL PATIENTS WERE IMPLANTED WITH THE UNKNOWN SYNTHES FEMORAL NECK SYSTEM. ALL PATIENTS WERE FOLLOWED AND EVALUATED AT 2-, 6- AND 12-WEEK POSTOPERATIVE. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD PNEUMONIA AND URINARY TRACT INFECTION WHICH WERE BOTH SUCCESSFULLY TREATED USING ANTIBIOTICS. A TOTAL OF 8 PATIENTS HAD PERSISTING PAIN IN THE AFFECTED HIP WITHIN 12 MONTHS POSTOPERATIVE. 4 OF THESE PATIENTS HAD AVASCULAR NECROSIS. THESE PATIENTS UNDERWENT CONVERSION TO TOTAL HIP ARTHROPLASTY. 2 OF THESE PATIENTS HAD CUT-OUT. THESE PATIENTS UNDERWENT CONVERSION TO TOTAL HIP ARTHROPLASTY. 2 SHOWED NO RADIOLOGICAL ABNORMALITIES IN FRACTURE HEALING AFTER 8 MONTHS BUT COMPLAINED OF THE IRRITATING OSTEOSYNTHESIS MATERIAL. IN THESE 2 PATIENTS, IMPLANTS WERE REMOVED 10 MONTHS AFTER PRIMARY SURGERY AND BOTH PATIENTS REHABILITATED UNEVENTFULLY AFTER REMOVAL WITHOUT FURTHER PAIN DURING FOLLOW-UP. THIS REPORT IS FOR THE UNKNOWN SYNTHES FEMORAL NECK SYSTEM. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS REGULATORY REPORT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534632 UNK - KITS/SETS: FNS IMPLANT KIT ORTHOSIS,PEDICLE,SPINAL FIXATION MNI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention