BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK - CONSTRUCTS: DHS/DCS

    MDR report key: 10397104 · Received August 12, 2020

    Report

    Report Number
    8030965-2020-05900
    Event Type
    Death
    Date Received
    August 12, 2020
    Report Date
    August 6, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PATIENTS INVOLVED THIS REPORT IS FOR AN UNK - CONSTRUCTS: DHS/DCS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE: UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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

    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: NUNN, D. (1988), SLIDING HIP SCREWS AND MEDIAL DISPLACEMENT OSTEOTOMY, JOURNAL OF THE ROYAL SOCIETY OF MEDICINE, VOL. 81, PAGES 140-142 (UNITED KINGDOM). THE PURPOSE OF THIS STUDY IS TO ANALYZE THE PATIENT WHO UNDERWENT MEDIAL DISPLACEMENT OSTEOTOMY USING SLIDING HIP SCREWS. A TOTAL OF 108 PATIENTS UNDERWENT COMPRESSION SCREW FIXATION OF TROCHANTERIC FRACTURES OF THE FEMUR. THE MEAN AGE WAS 75.8 YEARS. THERE WERE 47 UNSTABLE INTERTROCHANTERIC FRACTURES, 20 OF WHICH WERE TREATED BY A DISPLACEMENT OSTEOTOMY. IMPLANT USED WERE HOW MEDICA COMPRESSION HIP SCREW AT ST GEORGE'S, AND AO DYNAMIC HIP SCREW AT ST JAMES'. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 5 OF THE 47 PATIENTS DIED IN THE FOLLOW-UP PERIOD AND 6 WERE RE-OPERATED UPON. 22 PATIENTS HAD RADIOLOGICAL EVIDENCE OF EXTRUSION OF THE SCREW, THE FACTORS WHICH CORRELATED WITH FAILURE BEING A SUPERIOR POSITION OF THE SCREW IN 75% AND A LOW SERUM ALBUMIN IN 92%. 8 PATIENTS IN BOTH GROUPS OF UNSTABLE INJURIES DEMONSTRATED RADIOLOGICAL EXTRUSION OF THE SCREW. THERE WAS A HIGHER INCIDENCE OF MALPOSITION OF THE SCREW IN BOTH GROUPS; THE SCREW ENTERED THE SUPERIOR THIRD OF THE HEAD ON THE ANTEROPOSTERIOR VIEW. THERE WERE SOME PATIENTS, HOWEVER, IN WHOM THE SCREW HAD BEEN CORRECTLY POSITIONED AND YET STILL EXTRUDED. MEASURABLE COLLAPSE OF THE FRACTURES OCCURRED MORE FREQUENTLY IN THE FIXATIONS WHICH FAILED. 5 PATIENTS HAD ULTRASONICALLY DETECTED HEMATOMAS. THESE WERE THE 6 OF 47 PATIENTS THAT WERE RE-OPERATED. 2 PATIENTS HAD MAJOR WOUND INFECTIONS, AND BOTH EXTRUDED. THE FIXATION DEVICE WAS REMOVED; 1 SUBSEQUENTLY DIED AND THE OTHER UNITED WITH GROSS COXA VARA. 1 PATIENT HAD A TOTAL HIP REPLACEMENT AT A THIRD OPERATION AFTER REMOVAL OF THE SCREW LED TO PROGRESSIVE COXA VARA. 1 PATIENT HAD FIXATION REVISED WITH A SARMIENTO TYPE OF OSTEOTOMY BUT DIED SOON AFTER. 1 HAD THE DEVICE REMOVED FOR SYMPTOMATIC EXTRUSION, AND AGAIN UNITED IN GROSS COXA VARA, 1 HAD THE METAL REMOVED AND UNDERWENT A CORRECTIVE OSTEOTOMY AND GRAFTING PROCEDURE 18 MONTHS LATER FOR A PROGRESSIVE VARUS AND MALROTATION DEFORMITY. THIS REPORT IS FOR AN UNKNOWN SYNTHES AO DYNAMIC HIP SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863343 UNK - CONSTRUCTS: DHS/DCS APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death