BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5112140 · Received September 29, 2015

    Report

    Report Number
    2520274-2015-16231
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    September 18, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. ADDITIONAL NARRATIVE: KARAEMINOGULLARI, O; ET AL (2007) ANALYSIS OF OUTCOMES FOR SURGICALLY TREATED HIP FRACTURES IN PATIENTS UNDERGOING CHRONIC HEMODIALYSIS. THE JOURNAL OF BONE AND JOINT SURGERY, 89A: 2, 324-331 THIS REPORT IS FOR AN UNKNOWN PFN OR DSH(UNKNOWN QUANTITY/UNKNOWN LOT). ADD'L PRO CODE: HSB. DEBRIDEMENT. THE INVESTIGATION COULD NOT BE COMPLETED; 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 SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: KARAEMINOGULLARI, O; ET AL (2007) ANALYSIS OF OUTCOMES FOR SURGICALLY TREATED HIP FRACTURES IN PATIENTS UNDERGOING CHRONIC HEMODIALYSIS. THE JOURNAL OF BONE AND JOINT SURGERY, 89A: 2, 324-331. THE STUDY INVOLVED PATIENTS WITH END-STAGE RENAL DISEASE WHO WERE ADMITTED TO TWO HOSPITALS FOR THE TREATMENT OF A FEMORAL NECK OR INTERTROCHANTERIC FRACTURE BETWEEN 1994 AND 2003. TWENTY-NINE PATIENTS WITH THIRTY-TWO HIP FRACTURES WERE ANALYZED IN THREE GROUPS. OF THE ELEVEN INTERTROCHANTERIC FRACTURES IN GROUP 1, TWO WERE TREATED WITH A PROXIMAL FEMORAL NAIL (PFN), AND NINE WERE TREATED WITH A SLIDING HIP SCREW (DYNAMIC HIP SCREW; SYNTHES). THE THIRTEEN FEMORAL NECK FRACTURES (FOUR NONDISPLACED AND NINE DISPLACED) IN THE TEN PATIENTS IN GROUP 2 WERE ALL TREATED WITH PERCUTANEOUS SCREW FIXATION. THE OTHER EIGHT FEMORAL NECK FRACTURES (GROUP 3) WERE TREATED WITH UNIPOLAR HEMIARTHROPLASTY (FIVE HIPS) OR BIPOLAR HEMIARTHROPLASTY (THREE HIPS). GROUP 1 (ELEVEN HIPS): FIVE PATIENTS HAD NO COMPLICATIONS. FIVE HIPS WITH NONUNION, TWO HAD BEEN TREATED WITH A PROXIMAL FEMORAL NAIL AND THREE WITH A SLIDING HIP SCREW. OF THE OTHER FOUR HIPS WITH NONUNION, ONE WAS IN A PATIENT WHO WAS LOST TO FOLLOW-UP AFTER EIGHT MONTHS. FIVE OF THE ELEVEN PATIENTS DIED. FOUR OF THEM DIED IN THE FIRST YEAR AFTER HIP FRACTURE SURGERY. THESE PATIENTS INCLUDED ONE WHO DIED FROM RESPIRATORY FAILURE CAUSED BY PNEUMONIA TWO DAYS AFTER THE OPERATION, TWO WHO DIED OF CARDIO-PULMONARY ARREST AT FOUR AND SIX MONTHS, AND ONE WHO DIED SEVEN MONTHS AFTER SURGERY BECAUSE OF INFECTION-RELATED COMPLICATIONS. THE REMAINING PATIENT DIED OF CARDIO-PULMONARY ARREST SEVENTEEN MONTHS AFTER SURGERY. SURGICAL TREATMENT OF HIP FRACTURES IN PATIENTS WITH END-STAGE RENAL DISEASE WHO ARE ON CHRONIC HEMODIALYSIS IS ASSOCIATED WITH FREQUENT COMPLICATIONS AND A HIGH MORTALITY RATE. OSTEOSYNTHESIS IS AN ACCEPTABLE OPTION FOR TREATING INTERTROCHANTERIC FRACTURES AND NONDISPLACED FEMORAL NECK FRACTURES, BUT DISPLACED FEMORAL NECK FRACTURES SHOULD BE TREATED WITH HEMIARTHROPLASTY. THIS REPORT IS 2 OF 5 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PFN OR DHS AND REFERS TO SERIOUS INJURY OF CASE 4, UNKNOWN PATIENT WHO EXPERIENCED INFECTION, DEBRIDEMENT AND NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641868 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention