BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 13712741 · Received March 9, 2022

    Report

    Report Number
    2210968-2022-01598
    Event Type
    Injury
    Date Received
    March 9, 2022
    Date of Event
    January 1, 2019
    Report Date
    April 11, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: THE ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE, 7(1); DOI: 10.1177/232596711882030. NOTE: EVENTS REPORTED VIA (B)(4).

    Description of Event or Problem · 0

    TITLE: OUTCOMES AFTER THE OPERATIVE TREATMENT OF BUCKET-HANDLE MENISCAL TEARS IN CHILDREN AND ADOLESCENTS THE PURPOSE OF THIS REPORT WAS TO REVIEW THE DEMOGRAPHIC FEATURES, CLINICAL PRESENTATION, OPERATIVE DETAILS, CLINICAL OUTCOMES, AND RISK FACTORS FOR A REOPERATION AND FOR PERSISTENT PAIN IN A LARGE YOUNGER COHORT WITH OPERATIVELY TREATED BUCKET-HANDLE MENISCAL TEARS (BHMTS). BETWEEN OCTOBER 2002 AND FEBRUARY 2013, 280 PATIENTS WITH BHMT WHO WERE TREATED ARTHROSCOPICALLY WERE INCLUDED IN THE STUDY. THERE WERE 177 MALES AND 103 FEMALES WITH A MEAN AGE OF 15.5 ± 2.5 YEARS (RANGE, 2.1-19.2 YEARS). THERE WERE 99 PATIENTS WHO UNDERWENT MENISCECTOMY WHILE 181 PATIENTS UNDERWENT MENISCAL REPAIR. THE INSIDE-OUT REPAIRS WERE PERFORMED USING STANDARD ZONE-SPECIFIC MENISCAL REPAIR CANNULAS AND DOUBLE-ARMED NEEDLES WITH EITHER 2-0 NONABSORBABLE ETHIBOND (ETHICON), ABSORBABLE POLYDIOXANONE SUTURE PDS (ETHICON) OR A SIMILAR COMPETITOR DEVICE. ANALYSES OF REOPERATIONS AND OF SELF-REPORTED KNEE PAIN AT THE MOST RECENT FOLLOW-UP WERE RESTRICTED TO 185 OF THE 280-STUDY PATIENTS WITH A MINIMUM OF 6 MONTHS OF ADEQUATE FOLLOW-UP DATA. AMONG THESE 185 PATIENTS, THE MEAN FOLLOW-UP WAS 24.7 ± 20.6 MONTHS, AND THE MEDIAN WAS 16.7 MONTHS (RANGE, 6.0-97.5 MONTHS). COMPLICATIONS INCLUDE PERSISTENT PAIN (N=?) AND REOPERATION FOR MENISCUS-RELATED REASONS WHICH INCLUDED A RECURRENT BUCKET-HANDLE MENISCAL TEARS (N=?), A NON-BHMT RETEAR OF THE SAME MENISCUS (N=?), AND ARTHROFIBROSIS (N=?). IN CONCLUSION, MOST BHMTS IN YOUNGER PATIENTS OCCURRED IN MALES AND DURING SPORTS AND AFFECTED THE MEDIAL MENISCUS. CONCURRENT ANTERIOR CRUCIATE LIGAMENT SURGERY WAS INDICATED IN APPROXIMATELY ONE-THIRD OF CASES AND WAS ASSOCIATED WITH A LOWER REOPERATION RATE AND SLOWER RETURN TO SPORTS. TWO-THIRDS OF PATIENTS UNDERWENT MENISCAL REPAIR, OVER TWO-THIRDS OF WHOM DID NOT REQUIRE A REOPERATION DURING THE STUDY PERIOD, DESPITE THE HIGH ACTIVITY LEVELS IN THIS AGE GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2660009 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention