BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 38MM C

    MDR report key: 17306005 · Received July 12, 2023

    Report

    Report Number
    0001825034-2023-01534
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    June 28, 2020
    Report Date
    July 7, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: EP-200144 ACT ARTIC E1 HIP BRG 28X38MM LOT NUMBER IS UNKNOWN. 650-1159 DELTA CER FEM HD 28/-3MM T1 LOT UNKNOWN. 51-103090 TPRLC 133 TYPE1 PPS SO 9X137MM LOT NUMBER UNKNOWN. G2: FOREIGN: SOUTH KOREA. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT THA WAS PERFORMED WITH NO COMPLICATIONS NOTED. THE PATIENT EXPERIENCED A DISLOCATION AND UNDERWENT A REVISION SURGERY. THE HEAD WAS EXCHANGED BUT IT'S UNKNOWN IF THE LINER OR BEARING WAS EXCHANGED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034-2023-01535. 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 6 DAYS POST IMPLANTATION DUE TO DISLOCATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249733 G7 DUAL MOBILITY LINER 38MM C PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H