BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TAPERLOC STEM

    MDR report key: 11686216 · Received April 19, 2021

    Report

    Report Number
    0001825034-2021-01087
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 26, 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
    PL
    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 A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535.

    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 A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED ON UNKNOWN DATE IN 2006. CONCOMITANT MEDICAL PRODUCTS: 4011630001 ¿ REFOBACIN REVISION CEMENT ¿ UNKNOWN LOT. P0206L22 ¿ COCR HEAD ¿ UNKNOWN LOT. P0463044 ¿ AVAN CEMENTED CUP ¿ UNKNOWN LOT. P0560044 ¿ AVAN INSERT ¿ UNKNOWN LOT. REPORT SOURCE (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNING TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT HAS BEEN DISCARDED. 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 THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO IMPLANT FRACTURE. THE STEM COMPONENT HAD FRACTURED AT THE NECK. THE STEM, HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585018 UNKNOWN TAPERLOC STEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R