BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS CORD UNKNOWN PRODUCT

    MDR report key: 7110877 · Received December 12, 2017

    Report

    Report Number
    2210968-2017-71745
    Event Type
    Injury
    Date Received
    December 12, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 PDS CORD SUTURES CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR THE SUBJECTS OF THIS ARTICLE? IF SO, PLEASE ALSO INCLUDE: PATIENT INITIALS, INITIAL PROCEDURE DATE, PRE-EXISTING CONDITIONS, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT. IS THE PRODUCT CODE AND LOT NUMBER AVAILABLE FOR ANY OF THE ETHICON DEVICES USED? CITATION: ARCH ORTHOP TRAUMA SURG (2001) 121 :578¿582.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT REPAIR OF RUPTURED PATELLAR TENDON ON UNKNOWN DATE AND CORD SUTURE WAS USED FOR AUGMENTATION. THE STUDY FOCUSES ON COMPARING THE OUTCOME OF TWO METHODS OF AUGMENTATION. A REVIEW OF MEDICAL RECORDS FOR PATIENTS TREATED FROM 1980 TO 1999.THE FIRST PART OF THE STUDY, THE MEDICAL RECORDS OF PATIENTS WERE DIVIDED INTO 2 GROUPS: INDIRECT, LOW VELOCITY INJURIES AND HIGH-VELOCITY, COMPLEX KNEE TRAUMA OR KNEE LUXATIONS IN SECOND GROUP. FOLLOW-UP COMPARING THE 2 METHODS OF AUGMENTATION RANGED FROM 1 TO 18 YEARS, AVERAGING 8.1 YEARS. THE PATIENT IN SECOND GROUP POSSIBLY DEVELOPED POSTOPERATIVE WOUND INFECTION REQUIRING OPERATIVE REVISION. THE PATIENT POSSIBLY EXPERIENCED SEVERE PATELLOFEMORAL JOINT OSTEOARTHRITIC CHANGES WITH NO KNOWN RISK FACTOR FOR WEAKENING OF LIGAMENTOUS STRUCTURES. THE PATIENT MAY HAVE EXPERIENCED PATELLOFEMORAL SYMPTOMS SUCH AS DISCOMFORT UPON CLIMBING STAIRS OR ANTERIOR KNEE PAIN. THE AUTHORS STATED THAT A 1.3 CORD WITH SIMILAR TENSILE STRENGTH TO A 2MM CORD COULD POTENTIALLY REDUCE THE AMOUNT OF RETAINED MATERIAL AND SUBSEQUENTLY PREVENT WOUND HEALING PROBLEMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889932 PDS CORD UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention