BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD MOD HD 38MM STD NK

    MDR report key: 10456020 · Received August 26, 2020

    Report

    Report Number
    0001825034-2020-03221
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    November 12, 2019
    Report Date
    September 1, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K073102
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: CATALOG NUMBER: 15-105054 LOT NUMBER:356000 BRAND NAME: M2A 38 CUP; CATALOG NUMBER: 162032 LOT NUMBER:1673488 BRAND NAME: BI-METRIC HAP 12X140. SOURCE : (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01994, 0001825034-2020-01993. EVENT WAS INITIALLY REPORTED UNDER 3002806535-2020-00271. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED METAL IONS APPROXIMATELY 10 YEARS POST IMPLANTATION. PATIENT HAS BEEN ADDED TO A WAITING LIST FOR REVISION SURGERY, HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921362 CER BIOLOXD MOD HD 38MM STD NK PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 1620307

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other