BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMACUP SC SIZE 52MM

    MDR report key: 15441891 · Received September 16, 2022

    Report

    Report Number
    9610612-2022-00274
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    August 31, 2022
    Report Date
    October 17, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. CONCLUSION/MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IF THE DEVICE IS RETURNED IN THE FUTURE, AN INVESTIGATION WILL AGAIN BE COMPLETED AT THAT TIME. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NH052T - PLASMACUP SC SIZE 52MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT HAD RECURRENT DISLOCATIONS. THE INITIAL TOTAL HIP ARTHROPLASTY (THA) HAD BEEN PERFORMED TEN (10) YEARS AGO. A REVISION WAS PLANNED FOR (B)(6) 2022. THE CUP WAS TO BE REPLACED DUE TO LUXATION; THE SURGEON WAS ALSO CONSIDERING A 32MM HEAD. ADDITIONAL INFORMATION WAS REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE 400567883/100031444. INVOLVED COMPONENTS: NJ103 BIOLOX PROSTHESIS HEAD 8/10 28MM L (400567884), NH473 SC/MSC PE-INSERT 28MM 52/54 ASYM.(400567885), NJ214T BICONTACT D PLASMAPORE 8/10 SIZE 14MM (400567886).

    Description of Event or Problem · 0

    INVOLVED COMPONENTS: NJ103 BIOLOX PROSTHESIS HEAD 8/10 28MM L (400567884). NH473 SC/MSC PE-INSERT 28MM 52/54 ASYM.(400567885). NJ214T BICONTACT D PLASMAPORE 8/10 SIZE 14MM (400567886).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467567 PLASMACUP SC SIZE 52MM HIP ENDOPROSTHETICS PLW AESCULAP AG NH052T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention NH473 SC/MSC PE-INSERT 28MM 52/54 ASYM| NH473 SC/MSC PE-INSERT 28MM 52/54 ASYM.| NJ103 BIOLOX PROSTHESIS HEAD 8/10 28MM L| NJ103 BIOLOX PROSTHESIS HEAD 8/10 28MM L| NJ214T BICONTACT D PLASMAPORE 8/10 SIZE 14MM| NJ214T BICONTACT D PLASMAPORE 8/10 SIZE 14MM