BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM VIT E LINER +0MM

    MDR report key: 12939510 · Received December 6, 2021

    Report

    Report Number
    0001822565-2021-03498
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    November 3, 2021
    Report Date
    February 3, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K133378
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2021-03497. DEVICE PRODUCT CODE - PHX. CONCOMITANT PRODUCTS: ITEM# 00436003600; LOT# 64812131. ITEM# 00434901013; LOT# 64759362. ITEM# 01.04223.018; LOT# 2942443. ITEM# 01.04223.018; LOT# 2951969. ITEM# 00436201500; LOT# 64465978. REPORT SOURCE: FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. LINER IS NOT RELATED TO THE EVENT OF DISASSOCIATION OF THE HEAD FROM BASEPLATE. NO ALLEGATIONS AGAINST THE LINER. IT IS COMMON TO EXPLANT THE LINER AS THE ARTICULATION SURFACE WAS LIKELY COMPROMISED FROM THE HEAD BEING FREE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY SIX (6) DAYS POST-IMPLANTATION DUE TO THE GLENOID HEAD DISASSOCIATING FROM THE TRAY. BOTH THE GLENOID COMPONENT AND LINER WERE EXCHANGED IN THE REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. LINER IS NOT RELATED TO THE EVENT OF DISASSOCIATION OF THE HEAD FROM BASEPLATE. NO ALLEGATIONS AGAINST THE LINER. IT IS COMMON TO EXPLANT THE LINER AS THE ARTICULATION SURFACE WAS LIKELY COMPROMISED FROM THE HEAD BEING FREE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833725 36MM VIT E LINER +0MM PROSTHESIS, EXTREMITIES PHX ZIMMER BIOMET, INC. NI 64996344

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE NARRATIVE IN H10