BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR MOD HEAD

    MDR report key: 7321191 · Received March 7, 2018

    Report

    Report Number
    0001825034-2018-01731
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    January 10, 2017
    Report Date
    March 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM #: 51-199335, ITEM NAME: SIRIUS FEMORAL STEM, LOT #: 770833. ITEM #: 131352, ITEM NAME: RINGLOC ACETABULAR SHELL , LOT #: 2902081. ITEM #: XL-053252, ITEM NAME: RINGLOC-X ARCOM LINER, LOT #: 3306130. ITEM #: 66017569, ITEM NAME: PALACOS BONE CEMENT, LOT #: 78804375. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01734.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 3002806535-2018-00752.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN AND TROCHANTER BURSITIS APPROXIMATELY TWO YEARS POST-IMPLANTATION REQUIRING A STEROID INJECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164844 COCR MOD HEAD PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 0000716267

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention