BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFNA

    MDR report key: 9521924 · Received December 26, 2019

    Report

    Report Number
    8030965-2019-71501
    Event Type
    Injury
    Date Received
    December 26, 2019
    Report Date
    December 17, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PFNA CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KILINC B E, OC Y, KARA A, ERTURER RA (2018), THE EFFECT OF THE CERCLAGE WIRE IN THE TREATMENT OF SUBTROCHANTERIC FEMUR FRACTURE WITH THE LONG PROXIMAL FEMORAL NAIL: A REVIEW OF 52 CASES, INTERNATIONAL JOURNAL OF SURGERY, VOLUME 56, PAGE 250-255, (TURKEY). THE AIM OF THIS STUDY IS TO PRESENT THE EFFECT OF THE CERCLAGE FIXATION, WHICH WAS PERFORMED FOR THE PURPOSE OF PRESERVING THE ALIGNMENT OBTAINED BY OPEN REDUCTION, ON THE LONG-TERM CLINICAL AND RADIOLOGICAL RESULTS OF SUBTROCHANTERIC FRACTURES. BETWEEN JANUARY 2008 AND DECEMBER 2014, 52 PATIENTS WITH SUBTROCHANTERIC FRACTURES WHO WERE TREATED WITH LONG HIP NAILS AND CERCLAGE WIRE WERE INCLUDED IN THE STUDY. THERE WERE 32 FEMALES (MEAN AGE OF 77.80+/-9.75 YEARS, RANGE OF 46-94 YEARS) AND 20 MALES (MEAN AGE OF 79.18+/-6.50 YEARS, RANGE OF 23-92 YEARS). ALL PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES LONG PROXIMAL FEMORAL NAIL ANTIROTATION (300-420MM) AND A COMPETITOR¿S CERCLAGE WIRE. THE PATIENTS WERE CALLED UP FOR ROUTINE FOLLOW-UP VISITS AFTER THE POSTOPERATIVE 6TH WEEK, 3RD MONTH, 6TH MONTH, 1ST YEAR AND 2ND YEAR. THE MEAN FOLLOW-UP PERIOD OF THE PATIENTS WAS 62.25 +/- 34.68 MONTHS. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT DEVELOPED IMPLANT BREAKAGE DESPITE A GOOD REDUCTION. (FIG. 4) REVISION SURGERY WAS PERFORMED. 2 PATIENTS DEVELOPED FRACTURE AROUND THE IMPLANT DUE TO FALLING DOWN AFTER THE UNION OF THE FRACTURE. FRACTURE REDUCTION USING A SINGLE WIRE WAS PREFERRED BY THESE PATIENTS. 3 PATIENTS DEVELOPED A SUPERFICIAL SURGICAL INFECTION THAT HEALED WITH ANTIBIOTICS AND DRESSING. 2 PATIENTS HAD SEVERE WOUND DRAINAGE. DEBRIDEMENT WAS PERFORMED AND PATIENTS WERE TREATED WITH APPROPRIATE ANTIBIOTHERAPY ACCORDING TO CULTURE RESULT. THE DURATION OF THE UNION WAS OBSERVED TO BE LONGER IN THESE PATIENTS THAN IN OTHER PATIENTS. 1 PATIENT WAS IDENTIFIED TO HAVE AN IATROGENIC NON-DISPLACED FRACTURE OF THE TROCHANTER MAJOR DURING REAMING. THE UNION OF THE FRACTURE OCCURRED WITH CONSERVATIVE TREATMENT. 6 PATIENTS REPORTED 7/10 OF PAIN DURING LONG-DISTANCE WALKING. 1 PATIENT HAD A CUT-OUT. THIS REPORT IS FOR AN UNKNOWN SYNTHES PFNA CONSTRUCT. IT CAPTURES THE ADVERSE EVENTS OF FRACTURE, SUPERFICIAL INFECTION, SEVERE WOUND DRAINAGE, LONGER DURATION OF UNION AND PAIN. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312776 UNK - CONSTRUCTS: PFNA ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention