BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5110501 · Received September 29, 2015

    Report

    Report Number
    2520274-2015-16279
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    September 11, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. HIERHOLZER,C. ET AL (2011), OUTCOME ANALYSIS OF RETROGRADE NAILING AND LESS INVASIVE STABILIZATION SYSTEM IN DISTAL FEMORAL FRACTURES: A RETROSPECTIVE ANALYSIS. INDIAN JOURNAL OF ORTHOPAEDICS, MAY-JUN;45(3), PP. 243-250. ANTEROPOSTERIOR AND LATERAL RADIOGRAPHS OF LEFT KNEE OF A (B)(6) MAN WITH TYPE C3 OPEN DISTAL FEMUR FRACTURE, PATELLA FRACTURE AND PROXIMAL TIBIAL FRACTURE ON THE LEFT LEG; INITIAL TREATMENT WITH EXTERNAL FIXATOR AND TEMPORARY VACUUM ASSISTED CLOSURE. ANTEROPOSTERIOR AND LATERAL X-RAYS SHOW DEFINITIVE TREATMENT WITH LISS PLATE AFTER CONDITIONING OF SOFT TISSUES. NONUNION DEVELOPED AND WAS TREATED WITH RE-OSTEOSYNTHESIS, AND APPLICATION OF OSTEOGENIC PROTEIN 1 (OP1, BONE MORPHOGENETIC PROTEIN-7 (RHBMP-7)), AND CANCELLOUS BONE THAT RESULTED IN OSSEOUS UNION. THE PATELLAR AND UPPER TIBIAL IMPLANTS WERE REMOVED. THIS REPORT IS FOR AN UNKNOWN LESS INVASIVE STABILIZATION SYSTEM ( LISS) PLATE. (B)(4) IMPLANT REMOVAL. 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE. HIERHOLZER,C. ET AL (2011), OUTCOME ANALYSIS OF RETROGRADE NAILING AND LESS INVASIVE STABILIZATION SYSTEM IN DISTAL FEMORAL FRACTURES: A RETROSPECTIVE ANALYSIS. INDIAN JOURNAL OF ORTHOPAEDICS, MAY-JUN;45(3), PP. 243-250. THE PURPOSE OF THIS STUDY WAS TO EVALUATE AND COMPARE OUTCOME OF DISTAL FEMUR FRACTURE STABILIZATION USING RETROGRADE INTRAMEDULLARY (IM) NAILING (RN) OR LESS INVASIVE STABILIZATION SYSTEM (LISS) TECHNIQUES. IN A RETROSPECTIVE STUDY FROM JANUARY2003 TO DECEMBER 2008, 115 PATIENTS WITH DISTAL FEMUR FRACTURE, 59 PATIENTS WERE TREATED WITH RETROGRADE INTRAMEDULLARY (IM) SUPRACONDYLAR NAILING SYSTEM FROM ANOTHER MANUFACTURER OR 56 PATIENTS WITH LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE OSTEOSYNTHESIS, (SYNTHES, (B)(4)). IN THE TWO COHORT GROUPS, 74 PATIENTS WERE MEN AND 41 WERE WOMEN WITH A MEAN AGE OF 54 YEARS (RANGE 17-89 YEARS). THE EXCLUSION CRITERIA TO USE A RETROGRADE IM NAIL WAS A TYPE C2 OR C3 FRACTURE. IN THESE CASES, A LISS PLATE OSTEOSYNTHESIS WAS PERFORMED. FRACTURES WERE CLASSIFIED ACCORDING TO AO CLASSIFICATION: THERE WERE 52 TYPE A FRACTURES (RN 31, LISS 21) AND 63 TYPE C FRACTURES (RN 28, LISS 35). 32% (N=19) AND 56% (N=31) WERE OPEN FRACTURES IN THE RN AND LISS GROUP, RESPECTIVELY. CLINICAL AND RADIOGRAPHIC EVALUATION DEMONSTRATED OSSEOUS HEALING WITHIN 6 MONTHS FOLLOWING RN AND FOLLOWING LISS PLATING IN OVER 90% OF PATIENTS. HOWEVER, NO STATISTICALLY SIGNIFICANT DIFFERENCES WERE FOUND FOR THE PARAMETERS TIME TO OSSEOUS HEALING, RATE OF NONUNION, AND POSTOPERATIVE COMPLICATIONS. THE FOLLOWING COMPLICATIONS WERE TREATED: HEMATOMA FORMATION (ONE PATIENT RN AND THREE PATIENTS LISS), DEEP INFECTION TREATED WITH PROGRAMMED WOUND LAVAGE, VACUUM THERAPY AND INTRAVENOUS HIGH-DOSE ANTIBIOTICS IN TWO PATIENTS IN LISS GROUP. THE ADDITIONAL SECONDARY BONE GRAFTING OR BONE SUBSTITUTE (BMP) WAS REQUIRED, 3 MONTHS AFTER THE PRIMARY OPERATION IN FOUR PATIENTS (7%) IN RN GROUP AND SIX (12%) IN LISS GROUP. IN THE LISS GROUP, NONUNION WAS OBSERVED IN 6 OUT OF 56 PATIENTS (12%). ANTEROPOSTERIOR AND LATERAL RADIOGRAPHS OF LEFT KNEE OF A (B)(6) MAN WITH TYPE C3 OPEN DISTAL FEMUR FRACTURE, PATELLA FRACTURE AND PROXIMAL TIBIAL FRACTURE ON THE LEFT LEG; INITIAL TREATMENT WITH EXTERNAL FIXATOR AND TEMPORARY VACUUM ASSISTED CLOSURE. ANTEROPOSTERIOR AND LATERAL X-RAYS SHOW DEFINITIVE TREATMENT WITH LISS PLATE AFTER CONDITIONING OF SOFT TISSUES. NONUNION DEVELOPED AND WAS TREATED WITH RE-OSTEOSYNTHESIS, AND APPLICATION OF OSTEOGENIC PROTEIN 1 (OP1, BONE MORPHOGENETIC PROTEIN-7 (RHBMP-7)), AND CANCELLOUS BONE THAT RESULTED IN OSSEOUS UNION. THE PATELLAR AND UPPER TIBIAL IMPLANTS WERE REMOVED. IN PATIENTS WHO POSTOPERATIVELY COMPLAINED ABOUT PERSISTING JOINT PAIN WITH MOTION OR WEIGHT BEARING AND WHOSE CONVENTIONAL X-RAY IMAGING DEMONSTRATED CLOSE PROXIMITY OF THE DISTAL SCREWS TO THE KNEE JOINT USING CONVENTIONAL X-RAY, A POSTOPERATIVE CT SCAN STUDY WAS PERFORMED TO DETERMINE INTRA-ARTICULAR POSITION OF HARDWARE. IN THE LISS GROUP, WE FOUND INTRA-ARTICULAR PENETRATION OF DISTAL SCREWS IN FOUR PATIENTS (7%) NECESSITATING EXCHANGE OF SCREWS. THIS REPORT IS 2 OF 3 FOR (B)(4), FOR AN UNKNOWN LESS INVASIVE STABILIZATION SYSTEM PLATE (LISS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641589 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention