BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 56F

    MDR report key: 14148393 · Received April 19, 2022

    Report

    Report Number
    0001825034-2022-00899
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    March 10, 2021
    Report Date
    May 25, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K121874
    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). SOURCE: (B)(6). 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: 0001825034-2022-00900. 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
    1411004 G7 PPS LTD ACET SHELL 56F PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6378239

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other