BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE, ABSORBABLE, SYNTHETIC

    MDR report key: 8966537 · Received September 5, 2019

    Report

    Report Number
    2210968-2019-86606
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A 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 PRODUCT (VICRYL TAPE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (VICRYL TAPE) INVOLVED? CITATION: BONE JOINT J 2017;99-B:344¿50; DOI:10.1302/0301-620X.99B3.37884. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: TRACHELOPLASTY WITH A FLEXIBLE OSTEOCHONDRAL FLAP". AUTHORS: A. J. METCALFE; D. A. CLARK; M. A. KEMP; J. D. ELDRIDGE. CITATION: BONE JOINT J 2017;99-B:344¿50; DOI:10.1302/0301-620X.99B3.37884. THE BEREITER TRACHELOPLASTY HAS BEEN USED IN OUR UNIT FOR 12 YEARS TO MANAGE RECURRENT PATELLAR INSTABILITY IN PATIENTS WITH SEVERE TROCHLEA DYSPLASIA. THE AIM OF THIS STUDY WAS TO DOCUMENT THE OUTCOME OF A LARGE CONSECUTIVE COHORT OF PATIENTS WHO HAVE UNDERGONE THIS OPERATION. BETWEEN JUNE 2002 AND 01 AUGUST 2013, 214 TRACHELOPLASTIES WERE CARRIED OUT IN 185 PATIENTS (FEMALE=133, MALE=52; MEAN AGE=21.3 YEARS, AGE RANGE 14-38). TWO VICRYL TAPES (ETHICON) WERE PLACED IN THE CENTRE OF THE GROOVE AND TIED OVER A BONE BRIDGE LATERALLY TO SECURE FLAP. REPORTED COMPLICATIONS INCLUDED PARTIAL DETACHMENT OF THE CARTILAGE FLAP (N=1) IN WHICH THE LOOSE FRAGMENT WAS REMOVED BY ARTHROSCOPY AND MICROFRACTURE IF THE EXPOSED BONE WAS PERFORMED; PERSISTENT POST-OPERATIVE COMPLEX REGIONAL PAIN SYNDROME (N=1); PERSISTENT AND UNEXPLAINED FOOT DROP (N=1) DESPITE NORMAL NERVE CONDUCTION STUDIES AND NORMAL MRI SCANS OF THE KNEE AND SPINE; FRANK DISLOCATION (N=2) IN WHICH THE PATIENT HAD MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION (MPFL); GENERAL PERCEIVED INSTABILITY (N=5) WHICH THE PATIENTS HAD RE-OPERATIONS; FEELING OF SUBLUXATION AND VISIBLE MAL-TRACKING INTO THE GROOVE IN EXTENSION (N=2) WHICH THE PATIENTS HAD RE-OPERATIONS; FURTHER DISLOCATIONS (N=8%) WHICH SIX PATIENTS STATED THAT THEIR INSTABILITY SYMPTOMS HAD BEEN IMPROVED BY THE OPERATION. IN CONCLUSION, PATIENTS WITH RECURRENT PATELLAR INSTABILITY AND SEVERE TROCHLEAR DYSPLASIA CAN BE SUCCESSFULLY TREATED WITH A BEREITER TRACHELOPLASTY. HIGH LEVELS OF SATISFACTION AND GOOD PATIENT REPORTED OUTCOMES CAN BE ACHIEVED WITH LOW RATES OF POST-OPERATIVE OSTEOARTHRITIS IN THE MEDIUM TERM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760304 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention