BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 7385379 · Received March 30, 2018

    Report

    Report Number
    8030965-2018-52618
    Event Type
    Injury
    Date Received
    March 30, 2018
    Report Date
    March 6, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN PROXIMAL FEMORAL NAILS (PFN). PART#, LOT# AND UDI # IS NOT AVAILABLE. DATES OF IMPLANT AND EXPLANT ARE UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN PROXIMAL FEMORAL NAILS (PFN). PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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 LITERATURE ARTICLE: F. MULLER ET AL. (2017). TOTAL HIP ARTHROPLASTY AFTER FAILED OSTEOSYNTHESIS OF PROXIMAL FEMORAL FRACTURES: REVISION AND MORTALITY OF 80 PATIENTS, JOURNAL OF ORTHOPAEDIC SURGERY, 25(2), 230949901771786. GERMANY. THE STUDY OBJECTIVE WAS TO REPORT THE RESULTS WITH TOTAL HIP ARTHROPLASTY (THA) AFTER FAILED OSTEOSYNTHESIS WITHIN A TREATMENT PERIOD OF 10 YEARS. THE STUDY INCLUDED 1314 CONSECUTIVE OSTEOSYNTHESIS PROCEDURES IN PATIENTS WITH PROXIMAL FEMORAL FRACTURES OVER A 10-YEAR PERIOD. A TOTAL OF 705 PROXIMAL FEMORAL NAILS (PFN) WERE IMPLANTED. THE FOLLOWING COMPLICATIONS WERE REPORTED: SEVENTEEN PATIENTS (17) HAD OSTEOSYNTHESIS FAILURE, FOUR (4) OF WHICH UNDERWENT A REMOVAL OF THE PFN AND A RE-OSTEOSYNTHESIS TO A TOTAL HIP ARTHROPLASTY WITH A COMPETITOR¿S DEVICE. ONE (B)(6) YEAR-OLD MALE HAD MEDIAL CUTOUT OF THE PFN BLADE ON THE RIGHT SIDE UNDERWENT A REMOVAL OF THE PFN AND A RE-OSTEOSYNTHESIS TO A TOTAL HIP ARTHROPLASTY WITH A COMPETITOR¿S DEVICE. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN PROXIMAL FEMORAL NAILS (PFN). THIS IS REPORT 1 OF 3 FOR PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229413 ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention