BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER NEUTRAL 28 MM I.D. SIZE FF FOR USE WITH 46 MM

    MDR report key: 10106741 · Received June 1, 2020

    Report

    Report Number
    0001822565-2020-01928
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    May 7, 2020
    Report Date
    March 12, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024149069
    PMA / PMN Number
    K151448
    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

    THE INVESTIGATION WAS REOPENED AS THE REPORTED LINER WAS RETURNED FOR EVALUATION. AS RETURNED, DAMAGE IN THE FORM OF THRU HOLES IS SEEN THAT RUNS ACROSS THE DIAMETER OF THE DEVICE AND FROM INNER SURFACE TO BACKSIDE SURFACE. THIS DAMAGE APPEARS TO HAVE OCCURRED DURING REMOVAL. THE DEVICE DOES NOT SHOW SIGNS OF DELAMINATION. ADDITIONAL INFORMATION PROVIDED DOES NOT CHANGE THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. 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 PRODUCTS: CATALOG NUMBER:00875304601, LOT NUMBER:64326501, BRAND NAME: TRILOGY SHELL. CATALOG NUMBER:163660, LOT NUMBER: J6303568, BRAND NAME: COCR HEAD. CATALOG NUMBER: 21-103202, LOT NUMBER: 6252580, BRAND NAME: TAPERLOC FEMORAL STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-01929. 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. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.

    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
    568530 LINER NEUTRAL 28 MM I.D. SIZE FF FOR USE WITH 46 MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64165957 00889024149069

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R SEE H10 NARRATIVE.