BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7681551 · Received July 12, 2018

    Report

    Report Number
    8030965-2018-54965
    Event Type
    Injury
    Date Received
    July 12, 2018
    Report Date
    June 14, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS FOUND IN THE LITERATURE ARTICLE. DATE DEVICE MIGRATION IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN TRAUMA PLATE /UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THERE ARE MULTIPLE UNKNOWN DATES OF IMPLANTATION BETWEEN (B)(6) 2011 AND (B)(6) 2013. IT IS UNKNOWN IF OR WHEN DEVICES WERE EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER PHONE NUMBER IS UNKNOWN. 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, 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: AGRAWAL, P. ET AL (2017), DYNAMIC HIP SCREW VERSUS PROXIMAL FEMUR LOCKING COMPRESSION PLATE IN INTERTROCHANTERIC FEMUR FRACTURES (AO 31A1 AND 31A2): A PROSPECTIVE RANDOMIZED STUDY, JOURNAL OF NATURAL SCIENCE, BIOLOGY AND MEDICINE, VOL. 8(1), PAGES 87-93 (INDIA). THE PURPOSE OF THIS RANDOMIZED PROSPECTIVE STUDY IS TO COMPARE AND EVALUATE THE FUNCTIONAL AND RADIOLOGICAL OUTCOME OF DYNAMIC HIP SYSTEM (DHS) AND PROXIMAL FEMUR LOCKING COMPRESSION PLATE (PFLCP) FOR INTERTROCHANTERIC FRACTURES. BETWEEN JUNE 2011 AND JUNE 2013, 52 PATIENTS WERE ENROLLED IN THE STUDY. THE 26 PATIENTS (17 MALE AND 9 FEMALE) WITH MEAN AGE OF 55.23 (RANGE, 24-76 YEARS) WERE TREATED WITH DYNAMIC HIP SYSTEM (DHS GROUP) WHILE 26 PATIENTS (15 MALE AND 11 FEMALE) WITH MEAN AGE OF 56.46 (RANGE, 23-78 YEARS) WERE TREATED WITH PROXIMAL FEMUR LOCKING COMPRESSION PLATE (PFLCP GROUP). FOLLOW-UP WAS DONE AT 6, 12, 16, AND 24 WEEKS, AND 3 MONTHLY THEREAFTER UNTIL RADIOLOGICAL UNION. THE FOLLOWING COMPLICATIONS FOR DHS GROUP WERE REPORTED AS FOLLOWS: THREE CASES OF HAVING FAIR FUNCTIONAL OUTCOME ACCORDING TO THE HARRIS HIP SCORE. ONE CASE OF HAVING POOR FUNCTIONAL OUTCOME ACCORDING TO THE HARRIS HIP SCORE. FIVE CASES OF TYPE 31A2 FRACTURE WITH SIGNIFICANT LIMB SHORTENING MEASURING (>2 CM) AT THE TIME OF RADIOLOGICAL UNION. ONE CASE OF TYPE 31A2 FRACTURE WITH MEDIALIZATION OF SHAFT. ONE CASE OF VARUS DEFORMITY. ONE CASE OF SUPERFICIAL WOUND INFECTION. ONE CASE OF NON-SPECIFIC HIP PAIN. ONE CASE OF IMPLANT CUT-OUT. THE FOLLOWING COMPLICATIONS FOR PFLCP GROUP WERE REPORTED AS FOLLOWS: TWO CASES OF HAVING FAIR FUNCTIONAL OUTCOME ACCORDING TO THE HARRIS HIP SCORE. ONE CASE OF HAVING POOR FUNCTIONAL OUTCOME ACCORDING TO THE HARRIS HIP SCORE. TWO CASES OF SUPERFICIAL WOUND INFECTION. TWO CASES NON-SPECIFIC HIP PAIN. ONE CASE OF NONUNION AND WAS MANAGED WITH BONE GRAFTING WITH RETENTION OF IMPLANT. THE PATIENT WAS A HEAVY SMOKER WITH HISTORY OF STEROID USE FOR SKIN DISORDER. THIS REPORT IS FOR AN UNKNOWN SYNTHES TRAUMA PLATE. THIS IS REPORT 3 OF 3 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524812 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention