BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFNA LONG

    MDR report key: 12343085 · Received August 19, 2021

    Report

    Report Number
    8030965-2021-06875
    Event Type
    Injury
    Date Received
    August 19, 2021
    Report Date
    July 21, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PFNA LONG/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: WANG, W.Y., ET AL. (2010), TREATMENT OF SUBTROCHANTERIC FEMORAL FRACTURE WITH LONG PROXIMAL FEMORAL NAIL ANTIROTATION, CHINESE JOURNAL OF TRAUMATOLOGY, VOL. 13(1), PAGES 37-41 (CHINA). THIS STUDY EVALUATED THE CLINICAL OUTCOME OF SUBTROCHANTERIC FEMORAL FRACTURES FIXED WITH LONG PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA-LONG). FROM OCTOBER 2006 TO FEBRUARY 2008, 25 CASES OF TRAUMATIC SUBTROCHANTERIC FRACTURES OF THE FEMUR WERE TREATED BY MEANS OF PFNA-LONG (SYNTHES GMBH, OBERDORF, SWITZERLAND). THERE WERE 21MALES AND 4 FEMALES, WITH THE RANGE OF 20 TO 58 YEARS (AVERAGE, 45.6 YEARS). THEMEAN FOLLOW-UP PERIOD WAS 16.1MONTHS (RANGE, 12-20 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT DEVELOPED SUPERFICIAL WOUND INFECTION, AND RECOVERED AFTER THE TREATMENT OF INTRAVENOUS ANTIBIOTICS WITHOUT SURGICAL INTERVENTION. 1 PATIENT HAD DELAYED UNION, WITH EVENTUAL UNION AT POSTOPERATIVE 48 WEEKS WITHOUT MECHANICAL FAILURE. 4 PATIENTS COMPLAINED OF HIP PAIN AFTER EXERTION. 1 PATIENT HAD KNEE STIFFNESS BECAUSE OF CONCOMITANT IPSILATERAL FRACTURE OF THE TIBIAL PLATEAU AND SHAFT. THIS REPORT IS FOR AN UNKNOWN SYNTHES PFNA-LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242488 UNK - CONSTRUCTS: PFNA LONG APPLIANCE, FIXATION, NAIL KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention