BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMACUP SC SIZE 50MM

    MDR report key: 15979540 · Received December 14, 2022

    Report

    Report Number
    9610612-2022-00373
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    December 6, 2022
    Report Date
    December 14, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    PLW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NH050T - PLASMACUP SC SIZE 50MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PRODUCT BROKE DURING SURGERY. IN THE X-RAY IMAGE, THE ANTEVERSION OF THE CUP WAS NOT SEEN, AND IT WAS RATHER BACKWARD. THE DISLOCATION RESISTANCE WAS IMPROVED BY CHANGING THE HEAD SIZE FROM M TO XL. A REVISION SURGERY WAS NECESSARY. THE INITIAL PROCEDURE HAD BEEN TOTAL HIP ARTHROPLASTY (THA); AND IT WAS NOTED THAT THE PATIENT EXPERIENCED DISLOCATION MANY TIMES. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE: (B)(4). INVOLVED COMPONENTS NJ211T - BICONTACT D PLASMAPORE 8/10 SIZE 11MM - LOT: 51664088, NJ107 - BIOLOX PROSTHESIS HEAD 8/10 32MM M - LOT: 51705304, NH102 - SC/MSC CERAMICS INSERT 32MM 48 - 51708119.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051596 PLASMACUP SC SIZE 50MM HIP ENDOPROSTHETICS PLW AESCULAP AG NH050T 51676348

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention NH102 - LOT 51708119| NJ107 - LOT 51705304| NJ211T - LOT 51664088