BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: AFN

    MDR report key: 11367258 · Received February 23, 2021

    Report

    Report Number
    2939274-2021-01026
    Event Type
    Injury
    Date Received
    February 23, 2021
    Report Date
    February 2, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510 K: THIS REPORT IS FOR AN UNK - CONSTRUCTS: AFN/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 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. 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: HATEM, M. ET AL (2021), FEMORAL DEROTATION OSTEOTOMY IMPROVES HIP AND SPINE FUNCTION IN PATIENTS WITH INCREASED OR DECREASED FEMORAL TORSION, ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, VOL 37 (1), PAGES 111-123 (USA). THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE OUTCOMES OF PROXIMAL FEMORAL DEROTATION OSTEOTOMY (PFDO) ON THE HIP AND SPINE FUNCTION OF PATIENTS WITH ABNORMAL FEMORAL TORSION. BETWEEN JULY 2014 TO FEBRUARY 2019, A TOTAL OF 34 PATIENTS (37 HIPS; 8 MALE AND 26 FEMALE) WITH AN AVERAGE AGE OF 33 YEARS (RANGE, 15-54 YEARS) UNDERWENT PROXIMAL FEMORAL DEROTATION OSTEOTOMY (PFDO). SURGERY WAS PERFORMED USING AN ANTEROGRADE FEMORAL NAIL (FEMORAL NAIL, SYNTHES, WEST CHESTER, PA). THE MEAN FOLLOW-UP WAS 24 MONTHS (RANGE, 12-65 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED: 1 PATIENT WITH INCREASED FEMORAL TORSION AND EHLERS DANLOS SYNDROME UNDERWENT A SECOND PFDO AT THE SAME HIP AT 28 MONTHS AFTER THE PRIMARY PFDO BECAUSE OF A LACK OF CLINICAL IMPROVEMENT AND LACK OF FEMORAL TORSION CORRECTION. 2 PATIENTS HAD A NONUNION OF THE OSTEOTOMY SITE. A REVISION PROCEDURE WITH A LARGER INTRAMEDULLARY NAIL ALLOWED THE CONSOLIDATION OF THE OSTEOTOMY IN BOTH PATIENTS. 1 PATIENT WAS OBSERVED TO HAVE A DELAYED UNION IN ONE FEMUR AND WAS SUCCESSFULLY TREATED WITH LOCKING SCREW REMOVAL AT 6 MONTHS AFTER THE PFDO. IN 4 HIPS, A NONSYMPTOMATIC GRADE 1 HETEROTOPIC OSSIFICATION WAS OBSERVED AT THE ENTRANCE POINT OF THE FEMORAL NAIL AT THE MOST RECENT RADIOGRAPHIC EXAMINATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES AFN CONSTRUCTS. THIS REPORT IS FOR (1) UNK - CONSTRUCTS: AFN. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262642 UNK - CONSTRUCTS: AFN ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention