BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ARTICULAR SURFACE

    MDR report key: 14955752 · Received July 8, 2022

    Report

    Report Number
    0001822565-2022-02020
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 11, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: UNKNOWN TIBIAL TRAY: CATALOG#NI, LOT#NI; UNKNOWN FEMORAL COMPONENT: CATALOG#NI, LOT#NI. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-02021 AND 0001822565-2022-02022. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE PRODUCTS THAT CONTRIBUTED TO THE EVENT WERE NOT MANUFACTURED BY ZIMMER BIOMET. THE INITIAL REPORT WAS FILED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED "INCREASED RISK OF BILIARY INFECTION AFTER BILIARY STENT PLACEMENT IN USERS OF PROTON PUMP INHIBITORS" PATIENT'S EXPERIENCED ADVERSE EVENTS AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES USING AND EVIS LUCERA DUODENOVIDEOSCOPE. OBJECTIVES: PROTON PUMP INHIBITORS (PPIS) ARE WIDELY PRESCRIBED MEDICATIONS FOR GASTRIC ACID-INDUCED DISEASES. DESPITE THE EFFECTIVENESS OF PPIS, RECENT EVIDENCE SUGGESTED AN INCREASED RISK OF VARIOUS BACTERIAL INFECTIONS IN PPI USERS. THE CURRENT STUDY WAS CONDUCTED TO EVALUATE THE RISK OF BILIARY INFECTION AFTER ENDOSCOPIC BILIARY STENT PLACEMENT IN REGULAR USERS OF PPIS. METHODS: CONSECUTIVE PATIENTS WITH A NATIVE PAPILLA WHO UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND STENT PLACEMENT FOR BILIARY STRICTURE BETWEEN JANUARY 2010 AND AUGUST 2019 WERE INCLUDED IN THIS RETROSPECTIVE STUDY. THE CUMULATIVE INCIDENCES OF BILIARY INFECTION WERE COMPARED BETWEEN REGULAR AND NON-REGULAR PPI USERS. RESULTS: DURING THE STUDY PERIOD, 270 REGULAR PPI USERS AND 146 NON-REGULAR PPI USERS WERE INCLUDED IN THE ANALYSES. AGE, GENDER, AND INDICATION OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WERE NOT DIFFERENT BETWEEN THE TWO GROUPS. THE INCIDENCES OF BILIARY INFECTION WERE 43% IN REGULAR PPI USERS AND 36% IN NON-REGULAR PPI USERS BUT THE TIME TO BILIARY INFECTION WAS SIGNIFICANTLY SHORTER IN REGULAR PPI USERS THAN IN NON-REGULAR USERS (28 VS. 87 DAYS, P = 0.01). THE CUMULATIVE INCIDENCE OF BILIARY INFECTION WAS SIGNIFICANTLY HIGHER IN REGULAR PPI USERS COMPARED WITH NON-REGULAR USERS (P = 0.008). THE MULTIVARIABLE COX REGRESSION ANALYSIS ALSO SHOWED A SIGNIFICANTLY HIGHER HAZARD RATIO OF BILIARY INFECTION IN REGULAR PPI USERS (1.62 [95% CONFIDENCE INTERVAL 1.16¿2.26; P = 0.005]). CONCLUSIONS: REGULAR PPI USE WAS ASSOCIATED WITH A HIGHER RISK OF BILIARY INFECTION AFTER ENDOSCOPIC BILIARY DRAINAGE. INAPPROPRIATE PPI USE SHOULD BE AVOIDED. THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104110 UNKNOWN ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R