BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE

    MDR report key: 8278597 · Received January 25, 2019

    Report

    Report Number
    8030965-2019-60375
    Event Type
    Injury
    Date Received
    January 25, 2019
    Report Date
    January 7, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07612334089830
    PMA / PMN Number
    K172872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: PART: 04.168.285S, LOT: L830070 , MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 26.MAR.2018, EXPIRY DATE: 01.MAR.2028. NON-STERILE 04.168.285 (60123907) / L681189 WAS USED. MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 08.MAR.2018. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, THAT THE PATIENT WAS EXAMINED BY THE FACILITY AND DECIDED TO PERFORM A BIPOLAR HIP ARTHROPLASTY (BHA) BECAUSE IMPLANT WAS MOST LIKELY TO CUT-OUT. ON (B)(6) 2019, PATIENT SUCCESSFULLY UNDERWENT BHA SURGERY. INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2018, FOR OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY WITH FEMORAL NECK SYSTEM (FNS) TO TREAT A FEMORAL NECK FRACTURE. TWO WEEKS AFTER, IT WAS CONFIRMED THAT THE PATIENT HAD A HIGH DEGREE OF IMPLANT DISLOCATION AND SHORTENING OF THE LEG. THE PATIENT WAS UNDER FOLLOW-UP OBSERVATION SINCE THEN. THE SURGEON COMMENTED THAT THE FRACTURE TYPE WAS PREDISPOSED TO SHEARING FORCE AND THE EVENT WAS PREDICTABLE. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72012 BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L830070 07612334089830

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention