BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 16033372 · Received December 22, 2022

    Report

    Report Number
    0009613350-2022-00677
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    February 2, 2022
    Report Date
    December 22, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    JDL
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BIOLOX OPTION, HEAD, M,36/0, TAPER 12/14, ITEM# 00-8777-036-02, LOT# 2935402. FOREIGN ¿ ITALY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2022-00556. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED: PRODUCT EVALUATION COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED, THEREFORE RESEARCH COULD NOT BE PERFORMED. DEVICES ARE USED FOR TREATMENT. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORD WERE PROVIDED AND REVIEWED. PATIENT IS FEMALE, AGE 68 AT THE MOMENT OF REVISION. INITIAL THA IN 2016 AND FIRST REVISION IN 2020 FOR FRACTURED INSERT. DURING REVISION, SURGEON ASSESSED THAT STEM AND ACETABULAR CUP WERE FOUND TO BE WELL POSITIONED AND OSTEOINTEGRATED. PRODUCTS WERE NOT RETURNED FOR INVESTIGATION AND PICTURES WERE NOT PROVIDED THEREFORE DEVICE EVALUATION COULD NOT BE PERFORMED. AT THE MOMENT OF MANUFACTURING, THE HEAD RESPECTED DESIGN SPECIFICATION. NO INFORMATION ON MANUFACTURING RECORDS COULD BE REVIEWED ON THE INSERT, AS ITEM AND LOT NUMBER WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2-YEAR POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880752 UNKNOWN LINER HIP PROSTHESIS JDL ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R