BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD -6MM NK

    MDR report key: 10106738 · Received June 1, 2020

    Report

    Report Number
    0001825034-2020-02163
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    May 7, 2020
    Report Date
    July 14, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ET
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). SOURCE: (B)(6). CONCOMITANT MEDICAL DEVICES: CATALOG NUMBER:00875304601 LOT NUMBER:64326501 BRAND NAME: TRILOGY SHELL; CATALOG NUMBER:00875100728 LOT NUMBER: 64165957 BRAND NAME: ACETABULAR LINER; CATALOG NUMBER: 21-103202 LOT NUMBER: 6252580 BRAND NAME: TAPERLOC FEMORAL STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-02164. 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. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL HIP SURGERY. APPROXIMATELY 2 WEEKS POST IMPLANTATION, THE PATIENT BEGAN EXPERIENCING DRAINAGE FROM THE WOUND. AN IRRIGATION AND DEBRIDEMENT PROCEDURE WAS PERFORMED. A FEW DAYS LATER, THE PATIENT DISLOCATED THE HIP AND WAS REVISED. THE ASSUMPTION OF A DEEP INFECTION WAS REPORTED. THE LINER WAS REVISED, WHICH WAS VISIBLY DELAMINATING. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568342 28MM DIA COCR MOD HD -6MM NK PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A J6303568

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R