BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM TI HEADLESS COMPRESSION SCREW/16MM THREAD/80MM

    MDR report key: 8816781 · Received July 23, 2019

    Report

    Report Number
    8030965-2019-66506
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    June 28, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819988507
    PMA / PMN Number
    K080943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART: 04.227.080, LOT: 9180154, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 30. SEPTEMBER 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS A COMPANY REPRESENTATIVE (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. 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 THAT ON AN UNKNOWN DATE, A TOTAL HIP REPLACEMENT WAS PERFORMED DUE TO A FEMORAL HEAD NECROSIS. INITIALLY, THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO TREAT A LEFT FEMORAL NECK FRACTURE ON (B)(6) 2017 WHERE THREE (3) HEADLESS COMPRESSION SCREWS (HCS) WERE USED TO FIX THE FRACTURED END DURING THE OPERATION. THE INTRAOPERATIVE FLUOROSCOPY SHOWED THAT THE INTERNAL FIXATION WAS IN GOOD POSITION AND THE FRACTURED END WAS ANATOMICALLY RESET. ON (B)(6) 2019, FEMORAL HEAD NECROSIS OCCURRED. AN INTERNAL FIXATION WAS REMOVED ON AN UNKNOWN DATE. PATIENT WAS STABLE. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611170 6.5MM TI HEADLESS COMPRESSION SCREW/16MM THREAD/80MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 9180154 07611819988507

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention