BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 52E

    MDR report key: 21786984 · Received April 7, 2025

    Report

    Report Number
    0001825034-2025-01011
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    November 21, 2024
    Report Date
    April 7, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: (B)(6), ITEM NAME: 36MM I.D. SIZE E NEUTRAL LINER, LOT #: 65255951. (B)(6), ITEM NAME: FEMORAL STEM CEMENTLESS COLLARED HIGH OFFSET 12/14 TAPER, SIZE 3, LOT #: 3074345. (B)(6), ITEM NAME: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER, 12/14, LOT #: 3090848. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 AND A HALF YEARS POST IMPLANTATION, THE PATIENT WAS GIVEN A DEPO-MEDROL INJECTION AS WELL AS PRESCRIBED MEDROL DOEPAK 4 MG TABLETS DUE TO GREATER TROCHANTER PAIN AS WELL AS BILATERAL KNEE PAIN. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957029 G7 PPS LTD ACET SHELL 52E PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. 7127194

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R PLEASE SEE H11.