BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 48C

    MDR report key: 10683774 · Received October 15, 2020

    Report

    Report Number
    0001825034-2020-03824
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 15, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 30103203-G7 VIT E NEUTRAL LNR 32MM C-64669012. 574202040-AVENIR CMPL HA HO COL SIZE 4-3012866. 00877503201-BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14-3013059. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT REQUIRED A WOUND DEBRIDEMENT DUE TO A SUPERFICIAL INFECTION APPROXIMATELY 1-MONTH POST IMPLANTATION. NO PRODUCT WAS EXCHANGED. PATIENT REPORTED SATISFACTION AND NO OTHER COMPLICATIONS. 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
    1150891 G7 PPS LTD ACET SHELL 48C PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6721216

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R