BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8575315 · Received May 2, 2019

    Report

    Report Number
    8030965-2019-63413
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    November 16, 2012
    Report Date
    April 5, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF 16 PATIENTS (13 MALE AND 3 FEMALE) WITH A MEAN AGE OF 10.2 YEARS (RANGE, 8-13 YEARS). EXACT DATE OF EVENT IS UNKNOWN; NOVEMBER 16, 2012 IS THE DATE THE LITERATURE ARTICLE WAS PUBLISHED. THIS REPORT IS FOR AN UNKNOWN HIP SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: FARSETTI, P ET AL, VALGUS EXTENSION FEMORAL OSTEOTOMY TO TREAT ¿¿HINGE ABDUCTION¿¿ IN PERTHES¿ DISEASE, JOURNAL OF CHILDREN ORTHOPAEDICS (2012) VOL. 6 NO.6 PP 463-46 DOI10.1007/S11832-012-0453-8. THIS REPORT AIMS TO EVALUATE THE RESULT OF FEMORAL VALGUS EXTENSION OSTEOTOMY (VGEO) OF 16 CASES OF PERTHES¿ DISEASE WITH ¿¿HINGE ABDUCTION¿ A COMPLICATION OF PERTHES¿ DISEASE CAUSED BY IMPINGEMENT OF THE EXTRUDED SUPEROLATERAL PORTION OF THE FEMORAL HEAD AGAINST THE LATERAL LIP OF THE ACETABULUM. FROM 1999 TO 2009 A TOTAL OF 16 PATIENTS (13 MALE AND 3 FEMALE) WITH A MEAN AGE OF 10.2 YEARS (RANGE, 8-13 YEARS) WITH UNILATERAL PERTHES DISEASE WHO DEVELOPED ¿HINGE ABDUCTION¿ AND TREATED WITH FEMORAL VALGUS EXTENSION OSTEOTOMY (VGEO) ACCEPTED THE REQUEST FOR FOLLOW-UP EVALUATION. TO FIX THE OSTEOTOMY, A 90 ANGLED BLADE-PLATE (SYNTHES¿MATHYS) WAS USED UNTIL 2007, AND, SINCE THEN, A NEW HIP SCREW PLATE WITH ANGULAR STABILITY (SYNTHES) HAS BEEN UTILIZED. THE AVERAGE AGE AT FOLLOW-UP WAS 17.4 YEARS (RANGE: 10.5¿24 YEARS). THE AVERAGE LENGTH OF FOLLOW-UP WAS 6.5 YEARS (RANGE: 2.5¿11 YEARS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 3 PATIENTS HAD OCCASIONAL PAIN IN THE GROIN OR THIGH AFTER PROLONGED WALKING OR STRENUOUS ACTIVITIES. 2 PATIENTS WERE STILL LIMPING DUE TO HIP ABDUCTOR WEAKNESS. 2 PATIENTS STILL SHOWED SOME HIP FLEXION GAIT, ALTHOUGH IT HAD MARKEDLY IMPROVED AFTER SURGERY, BECAUSE THEY LACKED HIP EXTENSION MOVEMENTS. 4 PATIENTS BOTH THE TRIRADIATE CARTILAGE AND PROXIMAL FEMORAL PHYSIS WERE STILL OPEN. 2 PATIENTS WITH SEVERE FLEXION¿ADDUCTION CONTRACTURE OF THE HIP AND LIMPING DEVELOPED GENU VALGUM DEFORMITY ON THE AFFECTED SIDE. THIS REPORT IS FOR AN UNKNOWN HIP SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369064 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention