BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK - CONSTRUCTS: DHS/DCS

    MDR report key: 10335541 · Received July 28, 2020

    Report

    Report Number
    8030965-2020-05374
    Event Type
    Death
    Date Received
    July 28, 2020
    Date of Event
    October 12, 2019
    Report Date
    July 8, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN DHS/DCS CONSTRUCT/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. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LOTZIEN S., ET AL (2020) TROCHANTERIC FEMORAL NONUNION IN PATIENTS AGED OVER 60 YEARS TREATED WITH DYNAMIC CONDYLAR SCREW, INJURY VOLUME 51 , PAGES 389-394 (GERMANY) HTTPS://DOI.ORG/10.1016/J.INJURY.2019.10.022. THIS RETROSPECTIVE STUDY AIMS TO INVESTIGATE PATIENTS AGED 60 YEARS OR OLDER WITH ASEPTIC TROCHANTERIC NONUNIONS TREATED WITH A DCS (DYNAMIC CONDYLAR SCREW; SYNTHES, BETTLACH, SWITZERLAND) AS A STANDARDIZED TREATMENT PROCEDURE, LOOKING AT OUTCOMES RE- GARDING HEALING RATE, IMPLANT-RELATED COMPLICATIONS AND SECONDARY SURGERIES. FROM JUNE 1996 THROUGH APRIL 2017, A TOTAL OF 21 (13 FEMALES AND 8 MALES) WITH AVERAGE AGE AT ADMITTANCE WAS 76.05 ( ±7.78) YEARS (MEDIAN = 77; RANGE 62¿96) PATIENTS WITH TROCHANTERIC NONUNIONS AND WERE TREATED WITH A DCS (DYNAMIC CONDYLAR SCREW; SYNTHES, BETTLACH, SWITZERLAND)(INDEX PROCEDURE) WERE IDENTIFIED. INITIAL FRACTURES WERE TREATED WITH IMN USING PFN AND GN IN 13 PATIENTS AND SLIDING SCREW FIXATION SYSTEMS USING DCS,DHS IN 8 PATIENTS. FOLLOW-UP ASSESSMENTS WERE PERFORMED SIX WEEKS, TWELVE WEEKS AND SIX MONTHS AFTER THE INDEX PROCEDURE BY REGULAR VIS- ITS AT OUR OUTPATIENT CLINIC. MEAN LENGTH OF FOLLOW-UP WAS 21.62 ( ±23.88) MONTHS (ME- DIAN = 13; RANGE 2 DAYS¿87 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (PATIENT NO. 1) A CASE OF A (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH DCS HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP AND ACHIEVED BONY UNION. (PATIENT NO. 4) A CASE OF A (B)(6) YEAR OLD MALE FRACTURE INITIALLY TREATED WITH DHS HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP AND ACHIEVED BONY UNION. (PATIENT NO. 5) A CASE OF A (B)(6) YEAR OLD MALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS THAT LEAD BONY UNION. (PATIENT NO. 6) A CASE OF A (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP THAT LED TO BONY UNION. (PATIENT NO. 9) A CASE OF AN (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH DHS HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP THAT LED TO BONY UNION. (PATIENT NO. 10) A CASE OF AN (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH DCS HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP THAT LED TO BONY UNION. (PATIENT NO. 12) A CASE OF A (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH DHS HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP ACHIEVED BONY UNION. (PATIENT NO. 13) A CASE OF A (B)(6) YEAR OLD MALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS ACHIEVED BONY UNION. (PATIENT NO. 14) A CASE OF A (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS ACHIEVED BONY UNION. (PATIENT NO. 16) A CASE OF A (B)(6) YEAR OLD MALE FRACTURE INITIALLY TREATED WITH DCS HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP. DECEASED. (PATIENT NO. 17) A CASE OF A (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH DHS HAD NONUNION AND WAS TREATED WITH DCS ACHIEVED BONY UNION. (PATIENT NO. 18) A CASE OF A (B)(6) YEAR OLD MALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP ACHIEVED BONY UNION. (PATIENT NO. 19) A CASE OF A (B)(6) YEAR OLD MALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP THAT LED TO BONY UNION. (PATIENT NO. 20) A CASE OF A (B)(6) YEAR OLD MALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS ACHIEVED BONY UNION. (PATIENT NO. 21) A CASE OF A (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP ACHIEVED BONY UNION. OTHER FOUR PATIENTS¿ HIPS SHOWED LIMITED RANGE OF MOTION, NEVERTHELESS WITH A MINIMUM OF 90 °OF HIP FLEXION. 3 PATIENTS COULD NOT WALK ANG USED WHEELCHAIRS. (PATIENT NO 2) A CASE OF AN (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH DCS HAD NONUNION AND WAS TREATED WITH DCS. UNDERWENT REVISION RE-ORIF+ BONE GRAFT THAT LEAD TO BONY UNION. (ONE OF THE 5 PATIENTS WHO RECEIVED SECONDARY REVISION SURGERY). (PATIENT NO. 3) A CASE OF A (B)(6) YEAR OLD MALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS. UNDERWENT REVISION FOR PERSISTENT NONUNION WITH ADDITIONAL PLATE + BONE GRAFTING THAT LED TO BONY HEALING.(ONE OF THE 5 PATIENTS WHO RECEIVED SECONDARY REVISION SURGERY) (PATIENT NO. 8) A CASE OF A (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP HAD IMPLANT FAILURE IN CONJUNCTION WITH PROGRESSIVE OSTEOARTHRITIS OF THE HIP LEAD TO THA 22 MONTHS AFTER INDEX PROCEDURE. ( ONE OF THE 5 PATIENTS WHO RECEIVED SECONDARY REVISION SURGERY). (PATIENT NO. 11)A CASE OF A (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS UNDERWENT REVISION : RESECTION ARTHROPLASTY. DECEASED. (PATIENT NO. 15) A CASE OF AN (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS AND UNDERWENT REVISION RE-ORIF .DECEASED ( ONE OF THE 5 PATIENTS WHO RECEIVED SECONDARY REVISION SURGERY). FIG. 1. (A) X-RAYS OF AN OTA TYPE 31 ¿A1.2 FEMORAL FRACTURE AND NONUNION SIX MONTHS AFTER NAILING; (B) X-RAYS SHOWING RE - ORIF WITH A PRECONTOURED DCS PLATE AND RESTORATION OF THE CCD; (C) FINAL X-RAYS OF THE SAME PATIENT SHOWING BONY HEALING FOUR MONTHS AFTER INDEX PROCEDURE. -FIG. 2. (A) X-RAYS OF A (B)(6) YEARS OLD MALE WITH AN OTA TYPE 31¿A3.3 TROCHANTERIC FEMORAL FRACTURE; (B) INITIAL FRACTURE TREATMENT UTILIZING A DHS; (C) SCREW CUT - OUT SIX MONTHS AFTER DHS IMPLEMENTATION; ( D) POSTOPERATIVE X-RAYS AFTER REVISION UTILIZ- ING A DCS + ADDITIONAL ANTERIOR LCDCP; ( E) FINAL X-RAYS OF THE SAME PATIENT SHOWING BONY HEALING THREE MONTHS AFTER REVISION. DEATH: A CASE OF A (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS UNDERWENT REVISION : RESECTION ARTHROPLASTY. DECEASED. A CASE OF AN (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS AND UNDERWENT REVISION RE-ORIF .DECEASED. A CASE OF A (B)(6) YEAR OLD MALE FRACTURE INITIALLY TREATED WITH DCS HAD NONUNION AND WAS TREATED WITH DCS WITH ADDITIONAL LCDCP. DECEASED. 1 PATIENT DECEASED WITHIN TWO WEEKS AFTER THE INDEX PROCEDURE. OF THE 5 PATIENTS WHO UNDERWENT REVISION, 4 SHOWED A PERSISTENT NONUNION, IN 3 PATIENTS, PERSISTENT NONUNION LED TO IMPLANT FAILURE AND 1 PATIENT SUFFERED A DEEP INFECTION REQUIRING REVISION SURGERY. IN TOTAL, TWELVE OF THE 21 NONUNIONS WERE ASSOCIATED WITH IMPLANT FAILURE AND ADMISSION TO OUR HOSPITAL. THIS REPORT IS FOR AN UNKNOWN SYNTHES DHS/DCS CONSTRUCT. IT CAPTURES A (B)(6) YEAR OLD FEMALE FRACTURE INITIALLY TREATED WITH PFN HAD NONUNION AND WAS TREATED WITH DCS UNDERWENT REVISION : RESECTION ARTHROPLASTY. DECEASED. THIS IS REPORT 2 OF 5 FOR (B)(4). THE COMPLAINT INVOLVES 41 DEVICES. THIS (B)(4) REPORTS 5 DEVICES, REMAINING DEVICES ARE REPORTED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798558 UNK - CONSTRUCTS: DHS/DCS APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| R