BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR 40MM GLENOSPHERE +3MM COCR

    MDR report key: 14713519 · Received June 16, 2022

    Report

    Report Number
    0001822565-2022-01812
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    March 31, 2022
    Report Date
    June 30, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00887868231261
    PMA / PMN Number
    K181611
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    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: 0001822565-2022-01235, 0001822565-2022-01026. PRODUCT DEVICE CODE - PHX. ITEM# 110031405; LOT# 65172689, ITEM# 110031428; LOT# 64862430, ITEM# 010000589; LOT# 001910, ITEM# 113636; LOT# 64964393. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. 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

    (B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 110030777, CR 40MM GLENOSPHERE +3MM COCR, LOT # 65054408. H6 - PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. REPORTED EVENT WAS CONFIRMED AS VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED A REVERSE SHOULDER MINI HUMERAL TRAY AND REVERSE SHOULDER BEARING WERE RETURNED. AS RETURNED, DAMAGE IS SEEN ARTICULATING SURFACE, BACKSIDE, AND RIM FEATURE OF THE BEARING. THE TRAY EXHIBITS DAMAGE / BURNISHING ON THE INNER SURFACE AND RIM FEATURES. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED FOR THE GLENOSPHERE; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION DUE TO DISLOCATION CAUSED BY DISASSOCIATION OF THE POLY BEARING AND TRAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253511 CR 40MM GLENOSPHERE +3MM COCR SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 65054408 00887868231261

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention| H