BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH - STERILE

    MDR report key: 8231948 · Received January 9, 2019

    Report

    Report Number
    8030965-2019-59671
    Event Type
    Injury
    Date Received
    January 9, 2019
    Date of Event
    January 1, 2018
    Report Date
    December 12, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07612334089816
    PMA / PMN Number
    K172872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. DATE OF EVENT: UNKNOWN DATE IN 2018. 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 · 0

    IT WAS FURTHER REPORTED THAT FEMORAL NECK BOLT HAD CUTOUT AND DISLOCATION WERE CONFIRMED. THE SURGEON COMMENTED, THAT THE BOLT AND THE ANTI-ROTATION SCREW WERE SLIGHTLY SHORTER THAN THE PROPER LENGTH; THIS WAS NOTED DURING FOLLOW UP. CONCOMITANT DEVICES: FEMORAL NECK SYSTEM PLATE (PART 04.168.000S, LOT L863152, QUANTITY (B)(4)); LOCKING SCREW (PART 412.215S, LOT L880427, QUANTITY (B)(4)).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART 04.168.275S, LOT L802753: MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: MARCH 16, 2018, EXPIRY DATE: MARCH 01, 2028. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES 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. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT REPORTED PAIN AROUND THE SURGICAL SITE AFTER THE OPERATION. INITIALLY, A FEMORAL NECK SYSTEM WAS APPLIED DURING SURGERY ON (B)(6) 2018. THE PATIENT IS IN THE HOSPITAL UNDER NO WEIGHT BEARING. THE SURGEON COMMENTED, THAT THE BOLT AND THE ANTI-ROTATION SCREW WERE SLIGHTLY SHORTER THAN THE PROPER LENGTH. BIPOLAR HIP ARTHROPLASTY REVISION WAS SUCCESSFULLY COMPLETED ON (B)(6) 2018. THIS REPORT IS FOR A FEMORAL NECK BOLT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24512 BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH - STERILE APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L802753 07612334089816

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention