BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFNA-II

    MDR report key: 12343479 · Received August 19, 2021

    Report

    Report Number
    8030965-2021-06892
    Event Type
    Injury
    Date Received
    August 19, 2021
    Report Date
    July 21, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PFNA-II/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GAVASKAR AS, SUBRAMANIAN M, TUMMALA NC (2012), RESULTS OF PROXIMAL FEMUR NAIL ANTIROTATION FOR LOW VELOCITYTROCHANTERIC FRACTURES IN ELDERLY, INDIAN J ORTHOP, VOLUME 46 (5), PAGES 556-560 (INDIA). THIS STUDY REPORTS THE RESULTS OF LOW VELOCITY TROCHANTERIC FRACTURES INTERNALLY FIXED BY PROXIMAL FEMUR NAIL ANTIROTATION. FROM DECEMBER 2008 TO APRIL 2010, 122 INDEPENDENTLY MOBILE PATIENTS OVER 65 YEARS ADMITTED WITH A TROCHANTERIC FRACTURE FOLLOWING A LOW VELOCITY FALL WERE INCLUDED IN THE STUDY. THERE WERE 69 FEMALES AND 53 MALES WITH A MEAN AGE OF 74 YEARS (RANGE, 66-96 YEARS). ALL PATIENTS WERE TREATED WITH THE UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL ANTIROTATION II. WEIGHT BEARING AS TOLERATED WAS ALLOWED ROUTINELY FROM THE DAY AFTER SURGERY IRRESPECTIVE OF THE FRACTURE SUBTYPE. PATIENTS WERE DISCHARGED WHEN THEY WERE ABLE TO WALK CONFIDENTLY WITH ASSISTANCE. FOLLOW UP ASSESSMENTS WERE CONDUCTED AT 6 WEEKS, 6 AND 12 MONTHS. THE MEAN FOLLOW-UP WAS 21 MONTHS (12¿28 MONTHS).FINAL ANALYSIS WAS PERFORMED BETWEEN MAY AND JULY 2011. COMPLICATIONS WERE REPORTED AS FOLLOWS: 17 PATIENTS HAD POOR FRACTURE REDUCTION. 36 PATIENTS HAD SLIGHT-TO-MODERATE ABDUCTOR WEAKNESS. 42 PATIENTS HAD ABDUCTOR LIMP. 14 PATIENTS HAD A VARUS COLLAPSE. 12 OF THESE WERE SEEN IN UNSTABLE FRACTURES AND 10 IN POORLY FIXED FRACTURES. 1 PATIENT HAD DELAYED UNION THAT WAS ADDRESSED WITH TOTAL HIP REPLACEMENT. A (B)(6) FEMALE HAD A VARUS COLLAPSE FOLLOWING STABILISATION OF A 31-A2 FRACTURE WITH A LARGE POSTEROMEDIAL FRAGMENT. 30 PATIENTS HAD POOR BLADE POSITION. 1 PATIENT HAD A HELICAL BLADE CUT OUT. 3 PATIENTS HAD MEDIAL MIGRATION OF THE HELICAL BLADE INTO THE HIP JOINT. 2 PATIENTS HAD SYMPTOMATIC BACK OUT OF THE HELICAL BLADE DUE TO EXCESSIVE SLIDING. 8 PATIENTS DIED. 3 IN THE ACUTE POSTOPERATIVE PERIOD DUE TO SYSTEMIC CAUSES AND 5 DURING FOLLOW-UP. THIS REPORT IS FOR THE UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL ANTIROTATION II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238522 UNK - CONSTRUCTS: PFNA-II APPLIANCE, FIXATION, NAIL KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1