BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUST 32MM FRDM LNR SZ22 +5MM

    MDR report key: 12861207 · Received November 23, 2021

    Report

    Report Number
    0001825034-2021-03172
    Event Type
    Injury
    Date Received
    November 23, 2021
    Report Date
    January 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D4, G3, H2, H3, H4, H6 REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. RADIOGRAPHS WERE REVIEWED BY A HEALTH CARE PROFESSIONAL AND IDENTIFIED THE FOLLOWING: TWO VIEWS OF THE LEFT SHOULDER DEMONSTRATE A REVERSE LEFT TOTAL SHOULDER ARTHROPLASTY WITH DISLOCATION. HOWEVER, IT WAS NOTED BY THE REP, PATIENT WAS DISLOCATED TO TAKE THE XRAY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: CP561655 CUST 32MM FRDM PROX HUM 094510; CP561656 CUST 75MM MOSAIC SEG 053370; CP561657 9X24MM 400LB SHRT CPS SPDL 053350; CP561408 MOSAIC/CPS SM TAP ADAPTER 4CM 022580; CP561650 CUST CENTERING SLEEVE SET 024830. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT PMI SHOULDER ARTHROPLASTY DUE TO BONE METASTASIS FROM CANCER. THE PATIENT HAS BEEN INDICATED FOR A REVISION TO REPLACE THE LINER DUE TO POLY WEAR AND DISLOCATION, HOWEVER, A REVISION HAS NOT BEEN REPORTED. THE SALES REP HAS REQUESTED A SPECIALTY DEVICE, BUT THEY WILL BE USING A COMPETITOR REPLACEMENT POLY DUE TO THE WAITING TIME QUOTED FROM OUR SPECIALTY DEVICE DEPARTMENT. THE POLY WILL BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PMI DEPARTMENT THAT PATIENT UNDERWENT LEFT PMI SHOULDER ARTHROPLASTY. THE PATIENT HAS BEEN INDICATED FOR A REVISION ELEVEN YEARS POST IMPLANTATION TO REPLACE THE LINER DUE TO POLY WEAR, HOWEVER, A REVISION HAS NOT BEEN REPORTED. THE SALES REP HAS REQUESTED A SPECIALTY DEVICE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759445 CUST 32MM FRDM LNR SZ22 +5MM PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 053340

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10