BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06063

    MDR report key: 3329710 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-06063
    Event Type
    Injury
    Date Received
    September 6, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: J ORTHOP TRAUMA 2007; 21:18-25. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: FUNCTIONAL OUTCOME IN TREATMENT OF UNSTABLE TROCHANTERIC AND SUBTROCHANTERIC FRACTURES WITH THE PROXIMAL FEMORAL NAIL AND THE MEDOFF SLIDING PLATE; WILHELMINA EKSTROM, CHARLOTTE KARLSSON-THUR, SUNE LARSSON, BJORN RAGNARSSON, AND KARL-AKKE ALBERTS; J ORTHOP TRAUMA 2007; 21:18-25 REPORTED: THE OUTCOMES BETWEEN THE PROXIMAL FEMORAL NAIL (PFN) AND THE MEDOFF SLIDING PLATE (MSP) OF 210 PATIENTS WITH UNSTABLE TROCHANTERIC OR SUBTROCHANTERIC FRACTURES WERE COMPARED. BOTH GROUPS HAD A MEAN AGE OF 82. THE PFN GROUP HAD AN AGE RANGE OF 48-96 YEARS: TROCHANTERIC 83 YEARS AND SUBTROCHANTERIC 77 YEARS. THEY ALSO HAD 75 PERCENT WOMEN AND 24 PERCENT MALES. THE MSP GROUP HAD AN AGE RANGE OF 52-97 YEARS: TROCHANTERIC 82 YEARS AND SUBTROCHANTERIC 83 YEARS. THEY HAD 75 PERCENT WOMEN AND 25 PERCENT MEN. OUT OF THE 210 PATIENTS, 110 WERE RANDOMIZED TO THE PFN GROUP. THIS REPORT ADDRESSES THE OUTCOMES OF THE PFN GROUP ONLY. NOTED COMPLICATIONS FOR THE PFN GROUP INCLUDED ONE FEMORAL SHAFT FRACTURE DURING SURGERY REQUIRING A RETURN TO THE OR TWO DAYS LATER WITH A LONGER PFN; 6 PATIENTS EXPERIENCED A CUT OUT OF THE IMPLANT THROUGH THE FEMORAL HEAD (3 OF THE 6 PATIENTS REQUIRED A SECONDARY SURGERY, TWO WITH A NEW PFN AND ADDED CEMENT AND THE THIRD PATIENT EVENTUALLY HAD A TOTAL HIP REPLACEMENT); AT 8 MONTHS POST OP, IT WAS NOTED THAT ANOTHER PATIENT HAD A FATIGUE FRACTURE AT THE FEMORAL NECK RESULTING IN A TOTAL HIP REPLACEMENT AFTER NON-OPERATIVE TREATMENT FAILED; AND FINALLY, AN ADDITIONAL FOUR PATIENTS HAD MINOR SECONDARY SURGERY (2 PATIENTS HAD REPOSITIONING OF A DISTAL LOCKING SCREW, 1 HAD AN EXTRACTION OF THE HIP PIN DUE TO LATERAL DISPLACEMENT AND ONE UNDERWENT SURGERY FOR THE REMOVAL OF A HEMATOMA). THIS REPORT IS FOR AN UNKNOWN PFN HIP PIN. THIS REPORT IS 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443305 JDW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention