BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: DHS/DCS

    MDR report key: 17801934 · Received September 22, 2023

    Report

    Report Number
    8030965-2023-12031
    Event Type
    Injury
    Date Received
    September 22, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 DHS SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D6: DATE OF IMPLANTATION IS AN UNKNOWN DATE BETWEEN JANUARY 2010 AND JANUARY 2020. 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: CAI LEYI. ET AL.,(2023),SHORT-TERM CLINICAL EFFECT OF FAILURE AFTER INTRACOLIC FIXATION OF THE ELDERLY FEMORAL THELOID WITH PROSTHETIC JOINT REPLACEMENT, JOURNAL OF WENZHOU MEDICAL UNIVERSITY, VOL.53 NO.3 PAGES 203-214 (CHINA). THIS STUDY AIMS TO INVESTIGATE THE SHORT-TERM CLINICAL EFFECT OF ARTIFICIAL JOINT REPLACEMENT AFTER FAILURE OF INTERNAL FIXATION OF FEMORAL TROCHANTERIC FRACTURE IN ELDERLY OSTEOPOROSIS PATIENTS. BETWEEN JANUARY 2010 AND JANUARY 2020, A TOTAL OF 20 PATIENTS WERE TREATED WITH ARTIFICIAL JOINT REPLACEMENT,14 MEN AND 6 WOMEN, AGED 65 TO 85 (74.7 -+ 5.8). SURGERY INCLUDED 15 CASES INTRAMEDULLARY SCREWS, 3 CASES OF DYNAMIC HIP SCREW (DHS) SYSTEM, 2 CASES OF IN-STEEL FIXING. OUTPATIENT FOLLOW UP AT 1, 3, 6, AND 12 MONTHS AFTER HOSPITAL DISCHARGE AND ADMINISTERED ANTIOSTEOPOROSIS THERAPY. THE ARTICLE DOES NOT PROVIDE SUFFICIENT INFORMATION TO IDENTIFY WHICH DEVICE MANUFACTURER IS ASSOCIATED WITH THE ADVERSE EVENT. AT LATE OUTPATIENT FOLLOW-UP, ONE PATIENT FELL AGAIN 1 MONTH AFTER SURGERY AND DIAGNOSED A PERIPHERAL PROSTHESIS FRACTURE, WITH AN OLDER PATIENT AND POOR BASIC CONDITION. THE FAMILY WAS RELUCTANT TO UNDERGO SURGERY AND DIED THREE MONTHS LATER. THE FOLLOWING COMPLICATIONS WERE REPORTED: ¿ 2 PATIENTS DEVELOPED PULMONARY INFECTIONS AFTER THE PROCEDURE. 1 PATIENT HAD HEART FAILURE, WHICH IMPROVED AFTER MEDICAL TREATMENT. PATIENT HAD SUPERFICIAL INFECTIONS THAT IMPROVED HEALING AFTER ORAL ANTIOXINS AND MOUTH-TO-MOUTH CHANGES. 1 PATIENT HAD X-RAYS INDICATING LEAKAGE OF CEMENT IN THE OUTER FEMUR BONE DISTAL FROM THE PROSTHESIS. CASE 1 FEMALE, 81 YEARS OF AGE, FELL AND SUFFERED A FRACTURE OF THE LEFT FEMORAL BULGE, WHICH WAS FIXED IN THE OUTER YARD AFTER CLOSURE. PAIN 6 MONTHS AFTER SURGERY, VISIT HOSPITAL, FIXED FAILURE X-RAY INDICATION, SCREW CUT. CASE 2 FEMALE, 78 YEARS OLD, 4 MONTHS AFTER THE RIGHT FEMORAL CARBOHYDRATE INTRAFOLIATION PROCEDURE WITH SCREW CUTTING, THE PATIENT REPORTED A MARKED PAIN ON THE RIGHT HIP. THIS REPORT IS FOR AN UNKNOWN SYNTHES DYNAMIC HIP SCREW (DHS) AND UNKNOWN SYNTHES CEMENT. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880640 UNK - SCREWS: DHS/DCS APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention