BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5433422 · Received February 12, 2016

    Report

    Report Number
    2520274-2016-10981
    Event Type
    Injury
    Date Received
    February 12, 2016
    Date of Event
    May 14, 2013
    Report Date
    January 20, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN LATERAL LOCKING PLATES, LCP PLATES. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). 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. JOHNSON, E.E,MD, OSUJI, C.,MD, TIMON,S.,MD(2013) "SURGICAL TECHNIQUE - TSCHERNE-JOHNSON EXTENSILE APPROACH FOR TIBIAL PLATEAU FRACTURES", CLINICAL ORTHOPAEDICS AND RELATED RESEARCH,471:PP. 2760-2767. THERE IS A STANDARD APPROACH TO LATERAL TIBIAL PLATEAU FRACTURES. THIS ARTICLE DESCRIBES AN ALTERNATIVE APPROACH TO INCREASE LATERAL PLATEAU JOINT EXPOSURE AND MAINTAIN ILIOTIBIAL BAND INSERTION TO GERDY'S TUBERCLE. RETROSPECTIVELY REVIEWED WERE 76 PATIENTS (TWO GROUPS), SCHATZKER TYPES I TO II AND IV TO VI FRACTURES (66 PATIENTS), BETWEEN 1989 AND 2005, AND 10 PATIENTS, WITH 10 BICONDYLAR POSTERIOR PLATEAU FRACTURES, FROM 2002 TO 2010. TEN PATIENTS, WITH POSTERIOR PLATEAU FRACTURES, RECEIVED ANTEROLATERAL PLATEAU INTRAARTICULAR OSTEOTOMY FOR EXPOSURE OF CENTROPOSTERIOR AND POSTEROLATERAL ARTICULAR DEPRESSION. AFTER ELEVATION AND GRAFTING OF THE ARTICULAR SURFACE, GERDY'S TUBERCLE-POSTERIOR IT BAND WAS REDUCED TO ITS ANATOMIC POSITION. LATERAL LOCKING PLATES, LCP PLATES (SYNTHES, INC, (B)(6)), WERE POSITIONED AGAINST THE LATERAL SHAFT AND ON TOP OF THE REDUCED GERDY'S TUBERCLE AND IT BAND INSERTION. MEASUREMENTS WERE PERFORMED ON PACS DIGITAL SYSTEMS USING DIGITAL RULERS ON BOTH AP, LATERAL, AND CT RADIOGRAPHS. FLUOROSCOPIC VIEWS WERE ALSO TAKEN. SIXTY-SIX PATIENTS WITH LATERAL PLATEAU COMBINED FRACTURES WERE LEFT FOR EVALUATION. THE AVERAGE AGE AT THE TIME OF SURGERY WAS 42.5 YEARS (RANGE, 20-81 YEARS). FORTY-TWO PATIENTS WERE MALE; 24 WERE FEMALE. THE MINIMUM WAS 12 MONTHS (MEAN, 4.1 YEARS; RANGE, 12 MONTHS TO 10 YEARS). FIFTY-ONE PATIENTS HAD SCHATZKER TYPE I TO II FRACTURES AND 15 TYPE V TO VI FRACTURES. THIRTY-FOUR OF THESE FRACTURES WERE IN THE RIGHT KNEE AND 32 WERE THE LEFT KNEE. OF THE SECOND GROUP OF 10 PATIENTS WITH EXTENSIVE FRACTURES OF THE POSTERIOR PLATEAU, ALL HAD AN ANTEROLATERAL PLATEAU INTRAARTICULAR OSTEOTOMY AND BILATERAL JOINT DISTRACTION. THERE WERE SEVEN MALES AND THREE FEMALES WITH AN AVERAGE AGE OF 50 YEARS (RANGE, 34-62 YEARS). ALL FRACTURES HAD OBLIQUE POSTEROMEDIAL PLATEAU SHEAR FRACTURES COMBINED WITH POSTEROCENTRAL AND POSTEROLATERAL DEPRESSION FRACTURES WITH INTACT ANTEROLATERAL PLATEAU CORTEX. IN THE GROUP OF 66 PATIENTS, FIVE PATIENTS HAD HARDWARE REMOVAL; TWO PATIENTS OLDER THAN 70 YEARS OF AGE WITH PREEXISTING KNEE ARTHRITIS HAD SUBSEQUENT TKA 5 AND 7 YEARS AFTER INJURY. IN THE GROUP OF 10 PATIENTS, ONE PATIENT HAD A PARTIAL LATERAL MENISCECTOMY FOR A MENISCUS TEAR 27 MONTHS AFTER THE INDEX PROCEDURE. TWO PATIENTS REQUESTED REMOVAL OF SYMPTOMATIC HARDWARE AT 12 AND 17 MONTHS FROM THE INDEX OPERATION. THERE WAS ONE PERIOPERATIVE WOUND INFECTION 3 WEEKS AFTER SURGERY. THIS WAS MANAGED WITH ACUTE DEBRIDEMENT AND 6 WEEKS OF INTRAVENOUS ANTIBIOTICS RESULTING IN COMPLETE RESOLUTION OF INFECTION. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN LATERAL LOCKING PLATES, LCP PLATES. THERE WAS ONE PERIOPERATIVE WOUND INFECTION 3 WEEKS AFTER SURGERY. THIS WAS MANAGED WITH DEBRIDEMENT AND 6 WEEKS OF INTRAVENOUS ANTIBIOTICS RESULTING IN COMPLETE RESOLUTION OF INFECTION. IN THE GROUP OF 10 PATIENTS, TWO PATIENTS REQUESTED REMOVAL OF SYMPTOMATIC HARDWARE AT 12 AND 17 MONTHS FROM THE INDEX OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90887 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention