BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 4699141 · Received April 16, 2015

    Report

    Report Number
    2520274-2015-13000
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Report Date
    April 7, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: (B)(4). THIS REPORT IS FOR UNKNOWN PROXIMAL FEMORAL NAIL, UNKNOWN QUANTITY, UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, KAPICIOGLU, M., ET AL., (2014). "HIP FRACTURES IN EXTREMELY OLD PATIENTS." JOURNAL OF ORTHOPAEDICS II, 136-141. THIS IS A RETROSPECTIVE REVIEW OF ALL PATIENTS DIAGNOSED WITH A HIP FRACTURE OLDER THAN 90-YEAR OLD AT A SINGLE INSTITUTION FROM 2007-2012. THIRTY-TWO PATIENTS AT A MEAN AGE OF 92.8 (90.4-102.2) WERE TREATED AND REPORTED AT A MEAN FOLLOW-UP OF 2.02 (+-1.35) YEARS. TEN PATIENTS WERE MALE AND TWENTY-TWO PATIENTS WERE FEMALE. PATIENTS WERE TREATED WITH EITHER OSTEOSYNTHESIS WITH A PROXIMAL FEMORAL NAIL (PFN, PFNA DEPUY SYNTHES, (B)(4)) OR CEMENTED BIPOLAR HEMIARTHROPLASTY (CBH, SPECTRON OR ECHELON SMITH & NEPHEW, (B)(4)). THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PROXIMAL FEMORAL NAIL AND REFERS TO 2 CASES OF BLADE RELATED PROBLEMS, (1) LATERAL SLIDING, (1) CUT OUT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254400 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1