BEUDAMED
    FDA Adverse Event Injury Summary report: N

    40MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER

    MDR report key: 18118654 · Received November 13, 2023

    Report

    Report Number
    0001822565-2023-02990
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    October 18, 2023
    Report Date
    February 20, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00889024269224
    PMA / PMN Number
    K130661
    Removal / Correction Number
    NI
    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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE THE ASSOCIATED REPORT: 0001822565 - 2023 - 02991. D10: CONCOMITANT MEDICAL PRODUCTS - PART NUMBER (LOT NUMBER): 00434901213 (63700625). ASSOCIATED PRODUCT INFORMATION: 00434901500 (63715593). 00434904011 (63653808). 01.04223.036 (2921546). 01.04223.036 (2921529). G2: FOREIGN - EVENT OCCURRED IN DENMARK. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE 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 THAT 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. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE BACKSIDE FEATURES ARE DAMAGED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A REVERSE-TYPE LEFT SHOULDER ARTHROPLASTY HAS BEEN PERFORMED. THERE IS NO FRACTURE OR IMPLANT LOOSENING. THERE IS MALALIGNMENT OF THE GLENOSPHERE-HUMERAL ARTICULATION CONSISTENT WITH POLYETHYLENE FRACTURE, WEAR OR DISPLACEMENT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PREVIOUSLY REPORTED REVERSE ARTHROPLASTY REVISION SURGERY ONE (1) YEAR AND TEN (10) MONTHS AGO DUE TO THE POLY COMPONENT DISASSOCIATING FROM THE STEM. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY ONE (1) WEEK AGO DUE TO THE POLY COMPONENT DISASSOCIATING FROM THE STEM AND PARTIAL SUBLUXATION. THE POLY WAS REMOVED AND REPLACED WITH A SPACER AND A RETENTIVE LINER. NO OTHER PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. 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
    234857 40MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 63554469 00889024269224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE NARRATIVE IN H10.