BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LMP IMPLANT SIZE 30

    MDR report key: 11942992 · Received June 4, 2021

    Report

    Report Number
    1651501-2021-00014
    Event Type
    Injury
    Date Received
    June 4, 2021
    Report Date
    September 29, 2021
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWH
    PMA / PMN Number
    K023531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TOE JOINT REPLACEMENT (LMP-30T LMP IMPLANT SIZE 30) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: IMPLANTATION DATE WAS ON (B)(6) 2021 AND IT WAS REPLACED ON (B)(6) 2021. TYPE OF SILASTIC IMPLANT USED FOR REVISION SURGERY IS WRIGHT MEDICAL LATERAL TOE AND PIN. LMP IMPLANT CAUSED FRACTURE AND THERE WERE NO TRAUMATIC OR CONTRIBUTING EVENTS PRIOR TO THE DISCOVERY OF THE FRACTURE. FRACTURE DATE WAS BETWEEN (B)(6) 2021 AND (B)(6) 2021.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A PATIENT HAD IMPLANTED A LMP SILICONE JOINT AND HER 2ND METATARSAL FRACTURED. THE IMPLANT WAS REMOVED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839547 LMP IMPLANT SIZE 30 TOE JOINT REPLACEMENT KWH ASCENSION ORTHOPEDICS CT0216230

    Patients

    Seq Age Sex Outcome Treatment
    1