BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METHA SHORT HIP STEM CAP SIZE 1

    MDR report key: 11495799 · Received March 16, 2021

    Report

    Report Number
    9610612-2021-00170
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 11, 2021
    Report Date
    April 16, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    LWJ
    UDI-DI
    04038653407866
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: 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: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. PRODUCT CODE LWJ WAS CHOSEN BECAUSE NONE WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NC081T - METHA SHORT HIP STEM CAP SIZE 1. ACCORDING TO THE COMPLAINT DESCRIPTION, THE METALLOSIS WITH LARGE OSTEOLYSES BEHIND THE ACETABULUM AND ON THE PROXIMAL FEMUR, CLEAR CORROSION SIGNS ON THE PLUG CONNECTION BETWEEN THE HEAD-NECK-CONE AND THE NECK-STEM-CONE. THE INLAY IS COMPLETELY WORN OUT WITHIN 6 YEARS. THE EXPLANTS ARE KEPT BY THE PATIENT AT HER EXPRESS REQUEST. IMPLANTATION: 2008, (B)(6) NC081T, NC088K, NH050T, NH202, NK529K. REVISION 10.02.2015: HTEP - ONLY CHANGE OF HEAD AND INLAY; NH202, 51953832 + SMITH AND NEPHEW BIOLEX OPTION KOPF 32S-12/14M STERILE (3849717694582, 7010877872). REVISION 11.02.2021: HTEP - COMPLETE CHANGE (STEM, CUP AND INLAY) DUE TO WEAR. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER ((B)(4)). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00169 ((B)(4) + NC088K). INVOLVED COMPONENTS: NH050T - PLASMACUP SC SIZE 50MM - 51484353. NH202 - SC/MSC PE-INSERT 32MM 48/50 SYM. - 51953832. AE-QAS-COMPET-IMP - COLLECT.NO.QAS IMPLANTS FROM COMPETITORS - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392970 METHA SHORT HIP STEM CAP SIZE 1 HIP ENDOPROSTHETICS LWJ AESCULAP AG NC081T 51480043 04038653407866

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention AE-QAS-COMPET-IMP - UNKNOWN.| AE-QAS-COMPET-IMP - UNKNOWN.| NH050T - 51484353.| NH050T - 51484353.| NH202 - 51953832.| NH202 - 51953832.