BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFNA

    MDR report key: 9612383 · Received January 21, 2020

    Report

    Report Number
    8030965-2020-00514
    Event Type
    Injury
    Date Received
    January 21, 2020
    Report Date
    December 30, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PFNA CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KIM SJ, PARK HS, LEE DW, LEE JW (2018), IS CALCIUM PHOSPHATE AUGMENTATION A VIABLE OPTION FOR OSTEOPOROTIC HIP FRACTURES?, OSTEOPOROSIS INTERNATIONAL, VOLUME 29, PAGE 2021-2028, (SOUTH KOREA). THE AIM WITH THIS RETROSPECTIVE STUDY WAS TO MEASURE WHETHER AUGMENTATION WITH RESORBABLE CALCIUM PHOSPHATE CEMENT COULD IMPROVE FRACTURE STABILITY IN OSTEOPOROTIC HIP FRACTURES. BETWEEN MARCH 2014 AND 2017, 82 PATIENTS UNDERWENT REDUCTION AND INTERNAL FIXATION WITH A SHORT FEMORAL NAIL FOR OSTEOPOROTIC, UNSTABLE INTERTROCHANTERIC FRACTURES WERE INCLUDED IN THE STUDY. THE AVERAGE AGE OF THE PATIENTS AT THE TIME OF SURGERY WAS 81.9 YEARS (RANGE, 65¿99 YEARS). PATIENTS WERE DIVIDED INTO 2 GROUPS: GROUP 1, COMPOSED OF 42 PATIENTS (18 MALES, AND 24 FEMALES, MEAN AGE: 82.3 YEARS, MEAN BODY WEIGHT: 50.5 KGS) TREATED WITH PROXIMAL FEMORAL NAIL ALONE AND GROUP 2, COMPOSED OF 40 PATIENTS (15 MALES AND 25 FEMALES, MEAN AGE, 81.6 YEARS, MEAN WEIGHT: 52.1 KGS) TREATED WITH SAME DEVICE COMBINED WITH CALCIUM PHOSPHATE CEMENT FOR AUGMENTATION. ALL PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA). PATIENTS WERE SEEN FOR FOLLOW-UP AT 1, 2, 4, AND 6 MONTHS AND THEN EVERY 6 MONTHS THEREAFTER, WITH CLINICAL AND RADIOGRAPHIC EVALUATIONS. MINIMUM FOLLOW-UP WAS 6 MONTHS (AVERAGE, 1.2 YEARS; RANGE, 0.5¿2.1 YEARS). COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP 1. 1 PATIENT HAD EXCESSIVE SCREW SLIDING. THE PATIENT REQUIRED FURTHER INTERVENTION BECAUSE OF SEVERE SKIN IRRITATION. SCREWS WERE EXCHANGED. 1 PATIENT HAD EXCESSIVE SCREW SLIDING AND LOSS OF REDUCTION AT 2 MONTHS AFTER SURGERY. THE PATIENT UNDERWENT REVISION WITH BIPOLAR HIP REPLACEMENT. (FIG. 2). 1 PATIENT HAD DEEP WOUND INFECTION AND REQUIRED SURGICAL DEBRIDEMENT AND A TOTAL HIP REPLACEMENT. THE PATIENT EVENTUALLY DIED OF RENAL FAILURE. 2 PATIENTS HAD A SUPERFICIAL WOUND INFECTION. 4 PATIENTS HAD MALUNION. UNKNOWN PATIENTS HAD SLIDING OF SCREWS. UNKNOWN PATIENTS HAD FEMORAL SHORTENING. UNKNOWN PATIENTS HAD VARUS COLLAPSE GROUP 2. 2 PATIENTS HAD A SUPERFICIAL WOUND INFECTION. UNKNOWN PATIENTS HAD SLIDING OF SCREWS. UNKNOWN PATIENTS HAD FEMORAL SHORTENING. UNKNOWN PATIENTS HAD VARUS COLLAPSE. THIS IS REPORT 2 OF 4 FOR (B)(4). THIS REPORT IS FOR THE UNKNOWN PFNA CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74719 UNK - CONSTRUCTS: PFNA ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention