BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5623849 · Received May 2, 2016

    Report

    Report Number
    2520274-2016-12392
    Event Type
    Injury
    Date Received
    May 2, 2016
    Report Date
    April 25, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AKALIN, Y., AKINCI, O., KAYALI, C., REISOGLU, A. COMPARISON OF LONG-TERM RESULTS OF DYNAMIC HIP SCREW AND AO 130 DEGREES BLADE PLATE IN ADULT TROCHANTERIC REGION FRACTURES (2010) ACTA ORTHOP TRAUMATOL TURC, 44(6):443-451. THIS REPORT IS FOR AN UNKNOWN AO 130 DEGREES BLADE PLATE. (B)(6). (B)(4). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE PROVIDED. 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 · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: AKALIN, Y., AKINCI, O., KAYALI, C., REISOGLU, A. COMPARISON OF LONG-TERM RESULTS OF DYNAMIC HIP SCREW AND AO 130 DEGREES BLADE PLATE IN ADULT TROCHANTERIC REGION FRACTURES (2010) ACTA ORTHOP TRAUMATOL TURC, 44(6):443-451. THE PRESENT STUDY AIMED TO EVALUATE THE LONG TERM TREATMENT RESULTS OF PATIENTS WITH TROCHANTERIC FRACTURES OF THE FEMUR TREATED WITH EITHER 135 DEGREES SLIDING DHS OR AO 130AP 157 PATIENTS WERE INCLUDED IN THIS STUDY BETWEEN SEPTEMBER 1988 AND JUNE 2002. 82 PATIENTS UNDERWENT DHS FIXATION, 75 UNDERWENT AO 130 DEGREES AP FIXATION. 39 (14.8%) DIED IN THE FIRST YEAR POSTOPERATIVELY. OF THE PATIENTS WHO DIED, 17 BELONGED TO THE DHS GROUP, AND 22 TO THE AP GROUP. FOUR PATIENTS DIED DURING THE POSTOPERATIVE PERIOD. CAUSES OF DEATH INCLUDED CARDIOVASCULAR INSUFFICIENCY, DIABETES, PULMONARY PROBLEMS, AND NEUROLOGICAL DISEASES. THE FOLLOWING COMPLICATIONS WERE SEEN: AP GROUP: SHORTENING, VARUS DEFORMITY, FEMORAL HEAD PERFORATION, ACETABULAR PROTRUSION, DEVICE BREAKAGE, PSEUDOARTHROSIS, AVASULAR NECROSIS, SEVERE AND MILD MALUNION, ROTATIONAL DEFORMITY, REOPERATION. DHS GROUP: SHORTENING, VARUS DEFORMITY, FEMORAL HEAD PERFORATION, AVASULAR NECROSIS, MILD MALUNION, REOPERATION. THIS REPORT IS FOR AN UNKNOWN AO 130 DEGREES BLADE PLATE AND WILL ADDRESS THE REPORTED EVENTS OF MALUNION, PROTRUSION, AND PERFORATION THAT MAY REQUIRE ADDITIONAL MEDICAL/SURGICAL INTERVENTIONS. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279253 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention