BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 10 DEG E1 LINER 36MM G

    MDR report key: 17739786 · Received September 13, 2023

    Report

    Report Number
    0001825034-2023-02160
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    September 4, 2019
    Report Date
    October 31, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526785
    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). D10: 51-113140 ITEM NAME TPRLC 133 TYPE1 BM SO 14.0 LOT # 6057581, 010000707 ITEM NAME G7 BONEMASTER LTD ACET SHL 60G LOT # 6332149. G2: FOREIGN: AUSTRALIA MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 02162, 0001825034 - 2023 - 02161. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. COMPLAINT CONFIRMED BASED ON EVALUATION OF THE PROVIDED MEDICAL RECORDS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: X-RAY REVIEW: THERE IS NO ABNORMAL RADIOLUCENCY OR EVIDENCE OF IMPLANT LOOSENING. THERE IS MALALIGNMENT WITH SUBLUXATION/DISLOCATION AS NOTED. RECORDS REVIEW: UNSTABLE, EXTENSIVE SCAR TISSUE- DEBRIDED. A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 7 MONTHS POST IMPLANTATION DUE TO PAIN, POSSIBLE POLY DISIMPACTION AND INSTABILITY. DURING THE SURGERY, THE POLY WAS FOUND INTACT AND EXTENSIVE SCAR TISSUE WAS DEBRIDED. ONLY THE HEAD WAS REVISED, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061118 G7 10 DEG E1 LINER 36MM G PROSTHETIC, HIP PBI ZIMMER BIOMET, INC. N/A 3959772 00880304526785

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H