BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 7882399 · Received September 17, 2018

    Report

    Report Number
    0001822565-2018-04993
    Event Type
    Injury
    Date Received
    September 17, 2018
    Report Date
    October 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). JOURNAL ARTICLE: ANDERS BRÜGGEMANN, HANS MALLMIN & NILS P HAILER (2018) DO DUAL-MOBILITY CUPS CEMENTED INTO POROUS TANTALUM SHELLS REDUCE THE RISK OF DISLOCATION AFTER SURGERY?, ACTA ORTHOPAEDICA, 89:2, 156-162, HTTPS://DOI.ORG/10.1080/17453674.2018.1432927. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: ITEM# UNKNOWN, UNKNOWN HEAD, LOT# UNKNOWN; ITEM# UNKNOWN, UNKNOWN STEM, LOT# UNKNOWN; ITEM# UNKNOWN, UNKNOWN CUP, LOT# UNKNOWN. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ONE PATIENT UNDERWENT A RE-REVISION OF PE LINER DUE TO INSTABILITY HOWEVER; REMAINS UNSTABLE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723396 UNKNOWN LINER PROSTHESIS HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R