BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CANNULATED

    MDR report key: 9909797 · Received April 1, 2020

    Report

    Report Number
    8030965-2020-02480
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    November 11, 2016
    Report Date
    March 5, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF EVENT IS UNKNOWN; NOVEMBER 11, 2016 IS THE DATE THE LITERATURE ARTICLE WAS PUBLISHED. THIS REPORT IS FOR AN UNKNOWN 6.5MM AO CANNULATED SCREW/UNKNOWN LOT. PART AND LOT NUMBER 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. [(B)(4)].

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LU, Q.. ET AL. (2017), HEMIARTHROPLASTY VERSUS INTERNAL FIXATION IN SUPER-AGED PATIENTS WITH UNDISPLACED FEMORAL NECK FRACTURES: A 5-YEAR FOLLOW-UP OF RANDOMIZED CONTROLLED TRIAL, ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, VOL. 137, PAGES 27-35 (CHINA). THIS RANDOMIZED COMPARATIVE STUDY AIMS TO COMPARE THE EFFECTIVENESS AND LONG-TERM FOLLOW-UP RESULTS OF HEMIARTHROPLASTY (HA) WITH THAT OF MULTIPLE CANNULATED SCREWS (MCS) IN TREATING SUPER-AGED PATIENTS WITH UNDISPLACED FEMORAL NECK FRACTURES. FROM JANUARY 2008 TO DECEMBER 2010, A TOTAL OF 78 PATIENTS (20 MALES AND 58 FEMALES) WITH AN AGE RANGE OF 80 - 100 YEARS WERE INCLUDED IN THE STUDY. 41 PATIENTS UNDERWENT INTERNAL FIXATION USING 3 6.5 MM CANNULATED SCREWS (AO) WHILE 37 PATIENTS UNDERWENT HEMIARTHROPLASTY USING AN ARTIFICIAL JOINT PROSTHESIS USED WAS A CEMENTED EXETER STEM (NON-SYNTHES) AND A BIPOLAR HEAD (NON-SYNTHES) WITH 28 MM DIAMETER INNER HEAD. THE FOLLOW-UP TIME RANGED FROM 1 TO 92 MONTHS, AVERAGED (38.68 ± 28.24) MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (B)(6)-YEAR-OLD MALE PATIENT HAD A NONUNION AND WAS REVISED WITH A HEMIARTHROPLASTY. THIS REPORT IS FOR AN UNKNOWN 6.5MM AO CANNULATED SCREW. THIS IS REPORT 3 OF 10 FOR PC-(B)(4). ADDITIONAL DEVICES FOR THIS ARTICLE ARE CAPTURED ON RELATED COMPLAINT PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374711 UNK - SCREWS: CANNULATED SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention