BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT

    MDR report key: 14148398 · Received April 19, 2022

    Report

    Report Number
    0001822565-2022-01069
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    March 10, 2021
    Report Date
    May 26, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024144620
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 00801802802, LOT NUMBER:63916779, BRAND NAME: COCR HEADS. CATALOG NUMBER:00811400200, LOT NUMBER:64046654, BRAND NAME: CPT STEMS. CATALOG NUMBER:EP-200150, LOT NUMBER:211640, BRAND NAME: ACT ARTIC E1 HIP BRG. CATALOG NUMBER:010000665, LOT NUMBER: 6378239, BRAND NAME: G7 SHELL. CATALOG NUMBER:110024464, LOT NUMBER: 857020, BRAND NAME: G7 MOBILITY LINER. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT: 0002648920-2022-00093. 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.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE EVENT IS NOT REPORTABLE AS THERE WAS AN ERROR IN HOSPITAL REPORTING, AND THE METAL LEVELS WERE NOT ELEVATED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HOSPITAL LAB INITIALLY REPORTED THE COBALT LEVELS IN THE UNIT NMOL/L, INSTEAD OF UG/L. CORRECT CONVERSIONS FOUND THAT THE PATIENT DID NOT HAVE ELEVATED COBALT LEVELS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED METAL ION LEVELS APPROXIMATELY 2 YEARS POST IMPLANTATION. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE EVENT IS NOT REPORTABLE AS THERE WAS AN ERROR IN HOSPITAL REPORTING, AND THE METAL LEVELS WERE NOT ELEVATED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HOSPITAL LAB INITIALLY REPORTED THE COBALT LEVELS IN THE UNIT NMOL/L, INSTEAD OF UG/L. CORRECT CONVERSIONS FOUND THAT THE PATIENT DID NOT HAVE ELEVATED COBALT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411009 FEMORAL HEAD STERILE PRODUCT PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63916779 00889024144620

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other