BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BONEMASTER LTD ACET SHL 58G

    MDR report key: 12606781 · Received October 11, 2021

    Report

    Report Number
    0001825034-2021-02828
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    March 1, 2021
    Report Date
    October 26, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304524651
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. NO INTERVENTION TO DATE FOR COMPLAINT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. NO INTERVENTION TO DATE FOR COMPLAINT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). YEAR OF BIRTH: (B)(6). CONCOMITANT PRODUCTS: 010000937 3761000 G7 HI-WALL E1 LINER 36MM G; 51-111130 3647752 TPRLC 133 FP TYPE1 BM HO 13.0. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 02829, 0001825034 - 2021 - 02830.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY THE PATIENT EXPERIENCED INTERMITTENT, SHARP PAIN BELOW THE WAIST TOWARD RIGHT HIP JOINT EXACERBATED BY SITTING. THE PATIENT WAS TREATED WITH MEDICATION. 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
    1508724 G7 BONEMASTER LTD ACET SHL 58G PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 3786916 00880304524651

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10 NARRATIVE