BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 15683517 · Received October 27, 2022

    Report

    Report Number
    2210968-2022-08855
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    March 15, 2021
    Report Date
    October 27, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY (2022); 142:263¿270. HTTPS://DOI.ORG/10.1007/S00402-021-03825-Z.

    Description of Event or Problem · 0

    TITLE: CLINICAL AND RADIOGRAPHIC RESULTS AFTER ARTHROSCOPIC REPAIR OF LATERAL MENISCUS TEAR IN LATERAL-DEPRESSION TIBIAL PLATEAU FRACTURE. THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO EVALUATE THE CLINICAL AND RADIOGRAPHIC RESULTS OF ARTHROSCOPY-ASSISTED REDUCTION WITH INTERNAL FIXATION (AR/IF) AND MENISCUS REPAIR FOR TREATING LATERAL MENISCUS (LM) TEARS ASSOCIATED WITH LATERAL TIBIAL PLATEAU FRACTURES AND TO IDENTIFY THE FACTORS ASSOCIATED WITH LM TEAR. BETWEEN OCTOBER 2010 TO NOVEMBER 2016, A TOTAL OF 42 PATIENTS (26 MALE AND 16 FEMALE; MEAN AGE OF 47.2 ± 9.6 (17¿63) YEARS) WITH LATERAL TIBIAL PLATEAU FRACTURES (SCHATZKER TYPES II AND III ONLY) WERE INCLUDED AND TREATED WITH AR/IF. PERIPHERAL LONGITUDINAL TEARS OF THE LM WERE REPAIRED WITH THE INSIDE-OUT OR MODIFIED OUTSIDE-IN TECHNIQUE USING A SUTURE HOOK (LINVATEC, LARGO, FL, USA) WITH A STRAIGHT NECK AND A SPINAL NEEDLE PRELOADED WITH A NO. 0 NYLON, ENABLING THE OPERATOR TO PULL OUT THE PDS (POLYDIOXANONE SUTURE, ETHICON, USA). THE MEAN FOLLOW-UP PERIOD WAS 46.3 (RANGE: 24¿125) MONTHS. REPORTED COMPLICATIONS INCLUDE PARTIALLY HEALED LONGITUDINAL TEAR OF THE MENISCUS (N=1) WHICH WAS TREATED FURTHER WITH TWO STITCHES COMBINED WITH HARDWARE REMOVAL. IN CONCLUSION, LM TEARS ARE FREQUENTLY COMBINED WITH LATERAL TIBIAL PLATEAU FRACTURE, ESPECIALLY IN CORRELATION WITH MORE THAN 11 MM OF JOINT DEPRESSION, THOUGH MOST OF THOSE LESIONS CAN BE REPAIRED AT THE TIME OF FRACTURE FIXATION. AR/IF WITH ARTHROSCOPIC MENISCUS REPAIR COULD ACHIEVE GOOD CLINICAL AND RADIOGRAPHIC OUTCOMES WHEN TREATING SCHATZKER TYPES II AND III TIBIAL PLATEAU FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573000 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention