BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 36MM RLC LNR MROM SZ25

    MDR report key: 10904688 · Received November 25, 2020

    Report

    Report Number
    0001825034-2020-04197
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    November 4, 2020
    Report Date
    December 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 PROVIDED BY THE CUSTOMER. THE DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CASE IS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 12-115122 ¿ CERAMIC HEAD ¿ 2985986. 51-103160 ¿ TAPERLOC STEM ¿ 6695150. 103533 ¿ LOW PROFILE SCREW ¿ 185060. 103532 ¿ LOW PROFILE SCREW ¿ 821800. 13-104160 ¿ RINGLOC SHELL ¿ 587150. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO DISLOCATION. THE LINER AND RING WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370569 EPOLY 36MM RLC LNR MROM SZ25 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 268310

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R