BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL TAPE UNKNOWN

    MDR report key: 8966346 · Received September 5, 2019

    Report

    Report Number
    2210968-2019-86570
    Event Type
    Injury
    Date Received
    September 5, 2019
    Report Date
    August 13, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: KNEE SURG SPORTS TRAUMATOL ARTHROSC (2011) 19:1655¿1661; DOI 10.1007/S00167-011-1410-7. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE "TITLE : CLASSIFICATION OF TROCHLEAR DYSPLASIA AS PREDICTOR OF CLINICAL OUTCOME AFTER TROCHLEOPLASTY"AUTHOR : SANDRO F. FUCENTESE ¿ PATRICK O. ZINGG ¿JU¨RGEN SCHMITT ¿ CHRISTIAN W. A. PFIRRMANN ¿DOMINIK C. MEYER ¿ PETER P. KOCH CITATION: KNEE SURG SPORTS TRAUMATOL ARTHROSC (2011) 19:1655¿1661; DOI 10.1007/S00167-011-1410-7. SULCUS-DEEPENING TROCHLEOPLASTY RESTORES THE TROCHLEAR GROOVE IN PATIENTS WITH PATELLOFEMORAL INSTABILITY AND UNDERLYING TROCHLEAR DYSPLASIA. THE AIM OF THIS STUDY WAS TO IDENTIFY INFLUENCING FACTORS FOR THE CLINICAL OUTCOME FOLLOWING TROCHLEOPLASTY. BETWEEN 1999 AND 2006, 44 KNEES IN 38 PATIENTS (MALE=10, FEMALE=28; MEAN AGE=18 YEARS, AGE RANGE=14 ¿ 40 YEARS) UNDERWENT TROCHLEOPLASTY FOR THE TREATMENT FOR TROCHLEAR DYSPLASIA. THE GREATEST DEPTH THE GROOVE REACHES IS ABOUT 6 MM, WITH A SMOOTH GRADUATION AT EITHER END. THE OSTEOCHONDRAL FLAKE IS PRESSED INTO THE NEWLY FORMED GROOVE AND FIXED WITH TWO TRANSOSSEUS VICRYL NO. 5 SUTURES (VICRYL-TAPE, ETHICON) IN THE DEEPEST PART OF THE NEW TROCHLEA. THE SYNOVIUM IS REATTACHED TO THE CARTILAGINOUS EDGES WITH A CONTINUOUS ABSORBABLE SUTURE. THE TENDON OF THE VASTUS MEDIALIS OBLIQUUS MUSCLE (VMO) IS TIGHTENED MEDIALLY AND ATTACHED TO THE PATELLA WITH ONE CROSS-STITCH, AND THE JOINT IS CLOSED WITH A CONTINUOUS ABSORBABLE SUTURE WITHOUT CLOSING THE LATERAL RETINACULUM, LEAVING AN INDIRECT LATERAL RELEASE. REPORTED COMPLICATIONS INCLUDED INCREASED ONGOING PAIN (N=3) WHICH THE PATIENTS UNDERWENT FURTHER ARTHROSCOPIC DEBRIDEMENT WITH THE REMOVAL OF LOOSE BODIES IN ONE KNEE; NEW RECURRENT ATRAUMATIC DISLOCATION (N=1); PERSISTENT PAIN (N=2); AND COMPLEX REGIONAL PAIN SYNDROME (N=1). IN CONCLUSION, TROCHLEOPLASTY IS A USEFUL AND RELIABLE SURGICAL TECHNIQUE TO IMPROVE PATELLOFEMORAL INSTABILITY IN PATIENTS WITH A DYSPLASTIC TROCHLEA. WHILE IMPROVED STABILITY IS PREDICTABLE, PAIN IS LESS PREDICTABLE AND MAY EVEN INCREASE FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759860 VICRYL TAPE UNKNOWN SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention