BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/-3MM

    MDR report key: 15713500 · Received November 2, 2022

    Report

    Report Number
    3002806535-2022-00449
    Event Type
    Injury
    Date Received
    November 2, 2022
    Date of Event
    October 6, 2022
    Report Date
    December 29, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271168
    PMA / PMN Number
    K200959
    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). CONCOMITANT MEDICAL PRODUCTS: G7 BONEMASTER LTD ACET SHL 60G ITEM# 010000707 LOT# 6966249; G7 HI-WALL E1 LINER 36MM G ITEM# 010000937 LOT# 7210978. REPORT SOURCE: FOREIGN - AUSTRALIA. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, A3, B4, B5, G3, G6, H1, H2, H6, H10 . THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. GIVEN THIS INFORMATION, THIS COMPLAINT IS NOT-REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE HIP DUE TO INFECTION, APPROXIMATELY TWO (2) MONTHS POST-OP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    1285201 DELTA CERAMIC FEM HD 36/-3MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A 3090559 00887868271168

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H SEE H10 NARRATIVE