BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL TAPE UNKNOWN

    MDR report key: 8962412 · Received September 4, 2019

    Report

    Report Number
    2210968-2019-86571
    Event Type
    Injury
    Date Received
    September 4, 2019
    Report Date
    August 9, 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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL TAPE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? CITATION: KNEE SURG SPORTS TRAUMATOL ARTHROSC. 2014; 22: 2591¿2598. DOI: 10.1007/S00167-013-2603-Z. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL TAPE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: COMBINED TROCHLEOPLASTY AND MPFL RECONSTRUCTION FOR TREATMENT OF CHRONIC PATELLOFEMORAL INSTABILITY: A PROSPECTIVE MINIMUM 2-YEAR FOLLOW-UP STUDY" AUTHORS: INGO J. BANKE, LUDWIG M. KOHN, GEBHART MEIDINGER, ALEXANDER OTTO, DANIEL HENSLER, KNUT BEITZEL, ANDREAS B. IMHOFF, PHILIP B. SCHOTTLE CITATION: KNEE SURG SPORTS TRAUMATOL ARTHROSC. 2014; 22: 2591¿2598. DOI: 10.1007/S00167-013-2603-Z. EXCESSIVE TROCHLEAR DYSPLASIA MAY BE RESPONSIBLE FOR RECURRENT PATELLOFEMORAL INSTABILITY (PFI) DUE TO A MISSING BONY GUIDANCE FOR THE PATELLA IN EARLY FLEXION. IN THIS PROSPECTIVE STUDY, THE AUTHORS EVALUATED THE OUTCOME OF OPEN TROCHLEOPLASTY IN COMBINATION WITH MPFLR WITH A MINIMUM FOLLOW-UP OF 2 YEARS FOR TREATMENT OF EXCESSIVE PFI. BETWEEN 2007 AND 2009, 18 KNEES OF 17 CONSECUTIVE PATIENTS (MEAN AGE: 22.2 ± 4.9 YEARS; 11 MALE AND 6 FEMALE PATIENTS) WITH TROCHLEAR DYSPLASIA TYPE B, C OR D AND POSITIVE APPREHENSION FROM 0 TO 60 DEGREES OF FLEXION WERE INCLUDED. DURING THE TROCHLEOPLASTY PROCEDURE, THE SUBCHONDRAL TROCHLEAR GROOVE IS NEWLY REMODELLED BY DEEPENING (AND THEREBY LATERALIZATION) WITH A HIGH-SPEED BURR. THE TROCHLEAR OSTEOCHONDRAL FLAKE IS PRESSED INTO THE DEEPENED GROOVE AND REATTACHED BY VICRYL TAPE (ETHICON) OF 3 MM WIDTH AND THREE PUSHLOCK ANCHORS FROM ITS DEEPEST PART TO THE CORTEX OF THE MEDIAL AND LATERAL FEMORAL CONDYLE IN A STAR-SHAPED FASHION. REPORTED COMPLICATIONS INCLUDED ONE KNEE WITH PAINFUL MEDIAL SUBLUXATION OF THE PATELLA IN WHICH THE PATIENT UNDERWENT SUCCESSFUL PATELLA READJUSTMENT WITH BACKING OUT AND REINSERTING THE FEMORAL SCREW, TWO KNEES WITH PERSISTENT REDUCED RANGE OF MOVEMENT, IN WHICH THE PATIENT UNDERWENT SUCCESSFUL EARLY ARTHROSCOPIC ARTHROLYSIS, AND PAIN (N-1). IN THE 17 CONSECUTIVE PATIENTS ENROLLED IN THIS STUDY, COMBINED TREATMENT FOR TROCHLEOPLASTY WITH MPFLR SERVES AS A SUCCESSFUL THERAPY FOR CHRONIC PFI. SIGNIFICANT CLINICAL AND RADIOLOGICAL IMPROVEMENTS WERE OBSERVED. THIS COMBINATORY TREATMENT CONCEPT IS A RELIABLE OPTION NOT ONLY AS SALVAGE THERAPY BUT ALSO AS PRIMARY PROCEDURE REGARDING TREATMENT FOR CHRONIC PFI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756036 VICRYL TAPE UNKNOWN SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention