BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: DHS/DCS

    MDR report key: 10338146 · Received July 29, 2020

    Report

    Report Number
    2939274-2020-03317
    Event Type
    Injury
    Date Received
    July 29, 2020
    Report Date
    July 8, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: DHS/DCS/UNKNOWN LOT. PART AND LOT NUMBERS 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HAIDUKEWYCH, G.J., AND BERRY, D.J. (2004), NONUNION OF FRACTURES OF THE SUBTROCHANTERIC REGION OF THE FEMUR, CLINICAL ORTHOPAEDICS, VOL. 419, PAGES 185-188 (USA). THE PURPOSE OF THE CURRENT STUDY WAS TO REVIEW A LARGER CONSECUTIVE SERIES OF PATIENTS WITH NONUNION OR ACUTE FIXATION FAILURE OF SUBTROCHANTERIC FEMUR FRACTURES TREATED WITH CONTEMPORARY TECHNIQUES TO OBTAIN BONY UNION TO LEARN MORE ABOUT THE RESULTS, SUCCESS RATE, AND COMPLICATIONS ASSOCIATED WITH THE PROCEDURE. BETWEEN 1992 AND 2002, 23 PATIENTS WITH 23 FRACTURES OF THE SUBTROCHANTERIC REGION OF THE FEMUR WITH FAILURE OF A PREVIOUS INTERNAL FIXATION PROCEDURE WERE TREATED WITH ANOTHER OPERATION AIMED AT ACHIEVING BONY UNION. THERE WERE 16 MALES AND 7 FEMALES WITH AN AVERAGE AGE OF 55 YEARS (RANGE, 16¿88 YEARS). IMPLANTS USED TO TREAT THE ORIGINAL FRACTURE WERE: ORIGINAL FIXATION DEVICE WAS A SLIDING HIP SCREW IN 9 PATIENTS, A CEPHALOMEDULLARY NAIL WAS USED (3 RECONSTRUCTION [SMITH AND NEPHEW, MEMPHIS, TN], 2 GAMMA [STRYKER, HOWMEDICA, OSTEONICS, ALLENDALE, NJ], 1 INTRAMEDULLARY HIP SCREW [SMITH AND NEPHEW]) IN 6 PATIENTS, AN ANTEGRADE NAIL WITH PROXIMAL LOCKING INTO THE LESSER TROCHANTER WAS USED (SMITH AND NEPHEW) IN 4 PATIENTS, A 95° ANGLED BLADE PLATE WAS USED (SYNTHES, PAOLI, PA) IN 2 PATIENTS, A DYNAMIC CONDYLAR SCREW (SYNTHES) IN 1 PATIENT AND ENDERS NAILS WERE USED IN 1 PATIENT (SMITH AND NEPHEW). IMPLANTS USED FOR REVISION INTERNAL FIXATION WERE: 8 PATIENTS HAD REVISION SURGERY USING AN INTRAMEDULLARY NAIL WITH INTERLOCKING INTO THE FEMORAL NECK AND HEAD (7 WITH A RECONSTRUCTION NAIL [SMITH AND NEPHEW] AND 1 WITH A SYNTHES NAIL WITH A PROXIMAL SPIRAL BLADE), 7 PATIENTS HAD REVISION SURGERY USING A STANDARD ANTEGRADE FEMORAL NAIL WITH LOCKING INTO THE REGION OF THE LESSER TROCHANTER, 5 PATIENTS HAD REVISION SURGERY USING A 95° ANGLED BLADE PLATE (SYNTHES), 1 PATIENT HAD REVISION SURGERY USING A SLIDING HIP SCREW (SYNTHES), 1 PATIENT HAD REVISION SURGERY USING A 95 DYNAMIC CONDYLAR SCREW (SYNTHES), AND 1 PATIENT WAS TREATED WITH DUAL LOW-CONTACT DYNAMIC COMPRESSION (LCDC) PLATES (SYNTHES) WITH PROXIMAL CEMENT AUGMENTATION. CANCELLOUS AUTOGRAFT BONE WAS USED IN 8 PATIENTS, CANCELLOUS ALLOGRAFT BONE WAS USED IN 6 PATIENTS, AND BOTH WERE USED IN THREE PATIENTS. ONE PATIENT WITH 4 FAILED PREVIOUS NAILINGS WAS TREATED WITH A RECONSTRUCTION NAIL (SMITH AND NEPHEW), FREE FIBULAR TRANSFER, AND AUTOGRAFT CANCELLOUS BONE GRAFTING. THE MEAN CLINICAL FOLLOWUP FOR THE REMAINING 21 PATIENTS WAS 12 MONTHS (RANGE, 6¿39 MONTHS) AND THE MEAN RADIOGRAPHIC FOLLOWUP WAS 10 MONTHS (RANGE, 6¿39 MONTHS). THE ARTICLE DID NOT SPECIFY WHICH OF THE DEVICES WERE BEING USED TO CAPTURE THE FOLLOWING COMPLICATIONS: INITIAL SURGERY: 12 NONUNIONS ON THE RIGHT SIDE AND 11 ON THE LEFT SIDE. 21 OF 23 PATIENTS PRESENTED WITH ESTABLISHED NONUNIONS WITH A MEAN INTERVAL OF 21 MONTHS FROM THE ORIGINAL FRACTURE (RANGE, 6¿60 MONTHS). 12 OF 23 PATIENTS PREVIOUSLY HAD BEEN TREATED WITH ADDITIONAL ATTEMPTS TO GAIN BONY UNION AFTER THEIR ORIGINAL FRACTURE FIXATION. 5 OF THESE HAD 1 REOPERATION. 7 HAD 3 OR MORE PREVIOUS ATTEMPTS TO ACHIEVE BONY UNION BEFORE PRESENTATION. 2 PATIENTS PRESENTED WITH INFECTED NONUNIONS AND WERE TREATED WITH HARDWARE REMOVAL, DEBRIDEMENT, INTRAVENOUS ORGANISM-SPECIFIC ANTIBIOTICS, AND DELAYED RECONSTRUCTION AT 6 AND 8 WEEKS, RESPECTIVELY. 16 OF 21 PATIENTS HAD SEVERE PAIN, 4 HAD MODERATE PAIN, AND 1 HAD MILD PAIN. FIFTEEN PATIENTS REQUIRED TWO-ARM SUPPORT (A WALKER OR TWO CRUTCHES FULL-TIME), 1 PATIENT USED A CANE FULL-TIME, AND 5 PATIENTS WERE NONAMBULATORY. 2 PATIENTS HAD PROXIMAL FIXATION FAILURE AT 2 AND 3 MONTHS, RESPECTIVELY, AFTER THEIR ORIGINAL FRACTURE. REVISION SURGERY: 2 PATIENTS DIED AT THE LAST FOLLOW UP. A (B)(6)-YEAR-OLD MALE PATIENT WHO SMOKED TOBACCO AND WAS TREATED WITH A BLADE PLATE AND BONE ALLOGRAFT HAD A NONUNION THAT DID NOT HEAL. HIS FRACTURE WAS UNUNITED CLINICALLY AND RADIOGRAPHICALLY 19 MONTHS AFTER THE OPERATION BUT HE DID NOT WISH ADDITIONAL SURGERY. HE HAD SEVERE PAIN AND AMBULATED WITH A WALKER. 1 PATIENT HAD A POSTOPERATIVE ILEUS DEVELOP AND WAS TREATED MEDICALLY. 16 OF THE 20 PATIENTS WITH HEALED NONUNIONS (80%) HAD NO PAIN AND FOUR HAD MILD PAIN, ALL IN THE REGION OF THE GREATER TROCHANTER. IN EACH PATIENT THE TREATING PHYSICIAN THOUGHT THE RESIDUAL TROCHANTERIC AREA PAIN WAS CAUSED BY HARDWARE IRRITATION OR TROCHANTERIC BURSITIS. THIS IS REPORT 1 OF 7 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES CONSTRUCTS: DHS/DCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805879 UNK - CONSTRUCTS: DHS/DCS APPLIANCE, FIXATION, NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention