BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - PLATES: FNS

    MDR report key: 18419033 · Received December 29, 2023

    Report

    Report Number
    8030965-2023-16312
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    October 17, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4 ¿ 510K: THIS REPORT IS FOR AN UNKNOWN PLATE: FNS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: NIEMANN, M. ET AL (2023), RESTORATION OF HIP GEOMETRY AFTER FEMORAL NECK FRACTURE: A COMPARISON OF THE FEMORAL NECK SYSTEM (FNS) AND THE DYNAMIC HIP SCREW (DHS), LIFE, VOL. 13 (2073), PAGES 1-14 (GERMANY). THE AIM OF THIS STUDY WAS TO COMPARE RADIOGRAPHIC, CLINICAL, AND PATIENT-REPORTED OUTCOME MEASURES (PROMS) OF FEMORAL NECK FRACTURE PATIENTS FOLLOWING FNS COMPARED TO DYNAMIC HIP SCREW (DHS) IMPLANTATION COMBINED WITH AN ANTI-ROTATIONAL SCREW. BETWEEN (B)(6) 2020 AND (B)(6) 2022, A TOTAL OF 46 PATIENTS (22 FEMALE AND 24 MALE) WITH A MEDIAN AGE OF 66 YEARS (IQR 57, 75) WERE TREATED DUE TO A FEMORAL NECK FRACTURE WERE INCLUDED IN THE STUDY. AMONG THESE, 23 PATIENTS RECEIVED THE DHS (DYNAMIC HIP SCREW, DEPUY SYNTHES,WARSAW, IN, USA) COMBINED WITH AN ANTI-ROTATIONAL SCREW, AND 23 PATIENTS RECEIVED THE FNS (FEMORAL NECK SYSTEM, DEPUY SYNTHES). FOLLOW-UP PERIOD WAS 6 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: DHS GROUP: A 57-YEAR-OLD FEMALE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOLLOWING A FALL FROM STANDING HEIGHT. SHE HAD A PAUWELS TYPE 3, GARDEN TYPE 4 FRACTURE AND WAS TREATED WITH A DHS WITH AN ANTI-ROTATIONAL SCREW. DESPITE AN INITIALLY SATISFACTORY FOLLOW-UP, SHE PRESENTED WITH AN AVASCULAR NECROSIS OF THE FEMORAL HEAD SIX MONTHS FOLLOWING SURGERY, WHICH REQUIRED CONVERSION TO TOTAL HIP ARTHROPLASTY. 1 PATIENT DIED 25 MONTHS AFTER IMPLANTATION OF A DHS DUE TO UROSEPSIS. ELEVEN PATIENTS IN THE DHS GROUP REQUIRED REVISION SURGERY: - 3 PATIENTS REQUIRED REVISION SURGERY DUE TO IMPLANT-RELATED PAIN AND IMPLANTS WERE REMOVED. - 3 PATIENTS REQUIRED REVISION SURGERY DUE TO FEMORAL NECK SHORTENING UNDERWENT CONVERSION TOTAL HIP ARTHROPLASTY. - 1 PATIENT REQUIRED REVISION SURGERY DUE TO AVASCULAR NECROSIS UNDERWENT CONVERSION TOTAL HIP ARTHROPLASTY. - 2 PATIENTS REQUIRED REVISION DUE TO IMPAIRED WOUND HEALING WAS TREATED WITH LOCAL WOUND DEBRIDEMENT AND IMPLANT RETENTION. - 1 PATIENT REQUIRED REVISION SURGERY DUE TO PERSISTENT LOCAL HEMATOMA WAS TREATED WITH SURGICAL EVACUATION. - 1 PATIENT REQUIRED REVISION SURGERY DUE TO PERI-IMPLANT FRACTURE RECEIVED A CONVERSION PROXIMAL FEMORAL NAIL. FNS GROUP: A 67-YEAR-OLD MALE PATIENT PRESENTED WITH AN UNSTABLE FEMORAL NECK FRACTURE, WHICH WAS TREATED WITH AN FNS, BUT PRESENTED WITH IMPLANT CUT-OUT FOLLOWING SURGERY. 1 PATIENT DIED NINE MONTHS AFTER FNS IMPLANTATION FROM NATURAL CAUSES. 2 PATIENTS IN THE FNS GROUP REQUIRED REVISION SURGERY. - 1 PATIENT REQUIRED REVISION SURGERY DUE TO IMPLANT-RELATED PAIN AND IMPLANTS WERE REMOVED. - 1 PATIENT REQUIRED REVISION SURGERY DUE TO FEMORAL NECK SHORTENING UNDERWENT CONVERSION TOTAL HIP ARTHROPLASTY. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNK - PLATE: FNS. THIS IS REPORT 3 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665990 UNK - PLATES: FNS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown