BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BONEMASTER LTD ACET SHL 58G

    MDR report key: 14310632 · Received May 6, 2022

    Report

    Report Number
    0001825034-2022-01174
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    December 1, 2021
    Report Date
    May 25, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304524651
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT PRODUCTS: CATALOG NUMBER:110024465 LOT NUMBER:082030 BRAND NAME: G7 DUAL MOBILITY LINER. CATALOG NUMBER:010000706 LOT NUMBER:7013950 BRAND NAME: G7 BONEMASTER LTD SHELL. CATALOG NUMBER:51-117130 LOT NUMBER:6992376 BRAND NAME: TPRLC 133 MP TYPE1 BM. CATALOG NUMBER: 650-1159 LOT NUMBER:3066346 BRAND NAME: DELTA CER FEM HD 28/-3MM T1. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0001825034-2022-01173, 0001825034-2022-01175. 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. REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES 4 WEEKS POST OP PATIENT REPORTED LATERAL HIP PAIN, HIP STIFFNESS. NO OTHER COMPLICATIONS WERE NOTED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO (RELATED) DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    IT WAS REPORTED THAT THE PATIENT HAD TO HAVE STEROIDS INJECTION FOR HIP PAIN AND STIFFNESS APPROXIMATELY 4 WEEKS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253043 G7 BONEMASTER LTD ACET SHL 58G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 7013950 00880304524651

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| H