BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 23278377 · Received October 15, 2025

    Report

    Report Number
    2210968-2025-11682
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    December 19, 2024
    Report Date
    October 13, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: HAND SURG REHABIL. 2025 FEB;44(1):102068. HTTPS://DOI.ORG/10.1016/J.HANSUR.2024.102068 EPUB 2024 DEC 19. PMID: 39709159.

    Description of Event or Problem · 0

    TITLE: TREATMENT OF LONG FINGER METACARPOPHALANGEAL ARTHRITIS USING HAPY PYROCARBON INTERPOSITION IMPLANTS: A STUDY OF 34 CASES. THE AIM OF THIS SINGLER-CENTER OBSERVATIONAL DESCRIPTIVE STUDY IS TO PRESENT THE THIRTY-FOUR PATIENTS (61 IMPLANTS) WHO UNDERWENT METACARPOPHALANGEAL ARTHROPLASTY WITH THE HAPY1 IMPLANT, BETWEEN OCTOBER 2009 AND APRIL 2015. 3/0 OR 4/0 PDS SUTURES (ETH) WHICH WAS USED TO CORRECT VOLAR SUBLUXATION OR ULNAR DEVIATION. REPORTED COMPLICATIONS: 3/0 OR 4/0 PDS SUTURES (ETH) TYPE 1 COMPLEX REGIONAL PAIN SYNDROME (N=1) TREATMENT: NOT REPORTED SIGNIFICANT PAIN AND RESTRICTED RANGE OF MOTION (N=1) TREATMENT: NOT REPORTED IMPLANT DISLOCATION (N=1) TREATMENT: UNDERWENT REVISION SURGERY THE FOLLOWING DAY FOR A LARGER IMPLANT IN CONCLUSION, THE HAPY INTERPOSITIONAL IMPLANT PROVIDED GOOD CLINICAL AND RADIOGRAPHIC OUTCOMES FOR THE MANAGEMENT OF LONG FINGER ARTHRITIS, OFFERING FUNCTIONAL RESULTS AND IMPROVEMENT IN RANGE OF MOTION, COMPARABLE TO OTHER SERIES. THE HAPY INTERPOSITIONAL IMPLANT HAS THE ADVANTAGE OF BEING NONCONSTRAINED AND MAXIMIZING BONE STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179357 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention