BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINER

    MDR report key: 12576424 · Received October 5, 2021

    Report

    Report Number
    0001822565-2021-02794
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    May 3, 2021
    Report Date
    October 6, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND THE NEED FOR AN ADDITIONAL REPORT WILL BE PROCESSED UNDER MFR NUMBER: (B)(4).

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND THE NEED FOR AN ADDITIONAL REPORT WILL BE PROCESSED UNDER MFR NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 00811400110 FEMORAL STEM 12 ,LOT# 64560587; CAT# 63.32.50 LOW PROFILE CUP 32/50, LOT# 2881338. REPORT SOURCE: FOREIGN: COUNTRY: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD A FALL AT HOME CAUSING AN ACETABULAR DISLOCATION. DURING THE SURGERY IT WAS NOTED THAT THE PATIENT HAD AN INFECTION SO NO NEW IMPLANTS WERE PUT IN. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471630 UNK LINER PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O SEE H10 NARRATIVE.