BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II BLADE L90 TAN

    MDR report key: 8086852 · Received November 19, 2018

    Report

    Report Number
    8030965-2018-58359
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    January 1, 2018
    Report Date
    November 1, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819394223
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 · 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. ADDITIONAL INFORMATION PROVIDED. PART: 04.027.053S; LOT: L771426; MANUFACTURING SITE: BETTLACH; SUPPLIER: (B)(4); RELEASE TO WAREHOUSE DATE: FEBRUARY 16, 2018; EXPIRY DATE: FEBRUARY 01, 2028 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, VISUAL AND FUNCTIONAL 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 · 0

    THE IMPLANT PROTRUDED THROUGH THE FEMORAL HEAD AND DID NOT DETACH FROM THE BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE DUE TO A FEMORAL TROCHANTERIC FRACTURE. THE PATIENT WAS IMPLANTED WITH PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL, PFNA BLADE, LOCKING BOLT AND AN END CAP. THE PATIENT WAS UNDER A FULL WEIGHT BEARING REHABILITATION THE NEXT DAY AFTER THE SURGERY. ELEVEN WEEKS AFTER THE SURGERY, THE PATIENT EXPERIENCED PAIN. IT WAS THEN DISCOVERED THAT THE IMPLANT HAD CUT-OUT FROM THE FEMORAL HEAD. ON (B)(6) 2018, THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE. THE SURGEON BELIEVES THAT THE CUT-OUT OCCURRED DUE TO POOR BONE QUALITY THAT KEPT IT FROM HEALING. NO SURGICAL DELAY WAS REPORTED. PATIENT STATUS AND SURGICAL OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: PROXIMAL FEMORAL NAIL ANTIROTATION (PART# 472.105S, LOT# L888899, QUANTITY 1), LOCKING BOLTS (PART# 459.320VS, LOT# 5944882, QUANTITY 1), END CAP (PART# 473.170S, LOT# L785415, QUANTITY 1) THIS REPORT IS FOR ONE (1) PFNA-II BLADE L90 TAN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923751 PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH L771426 07611819394223

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention