BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE CEMENT DOUGHTYPE RADIOPAQUE 40 G POLYMER POWDER

    MDR report key: 7388714 · Received April 2, 2018

    Report

    Report Number
    0001526350-2018-00274
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    July 7, 2016
    Report Date
    April 2, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    LOD
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORDS FOR PN 00110201200, LN 63077590 WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH THE FOLLOWING UNRELATED ANOMALIES/DEVIATIONS IDENTIFIED: 10 PIECES WERE SCRAPPED AT MANUFACTURING STEP 50. THE SUPPLIER DEVICE HISTORY RECORDS FOR PN 00110205121, LN 80626754 WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH THE FOLLOWING UNRELATED ANOMALIES/DEVIATIONS IDENTIFIED: 17 BROKEN AMPOULES, 6 AMPOULES FOR OTHER REASONS AND 2 BLISTERS WERE REJECTED AND ARE SCRAPPED. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED THAT THE MONOMER LEAKED IN THE PACKAGING AS SEEN IN PICTURE 3 IN DL132216. THE REPORTED EVENT HAS BEEN CONFIRMED BY VISUAL INSPECTION. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS/ANOMALIES. IT HAS ALSO BEEN IDENTIFIED THAT THESE PRODUCTS ARE NO LONGER MANUFACTURED BY ZIMMER BIOMET IN (B)(4). ZWI IS IN PLACE THAT USES VISUAL AID 55-0000-310-01 TO 100% INSPECT FOR "DIRT, FIBER, LUMPS, OR ANY FOREIGN DEBRIS IN PACKAGING". THE PRODUCT MOST LIKELY LEFT ZIMMER BIOMET CONTROL CONFORMING BASED ON DHR REVIEW AND ZWI IN PLACE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS ARE NEEDED BASED ON THE ABOVE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AMPULE OF CEMENT WAS BROKEN WHEN THE CUSTOMER OPENED IT DURING PREPARATION DIRECTLY PRIOR TO SURGERY. THE CUSTOMER USED AND FINISHED THE SURGERY WITH AN ALTERNATIVE ONE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231156 BONE CEMENT DOUGHTYPE RADIOPAQUE 40 G POLYMER POWDER ZIMMER DOUGH-TYPE BONE CEMENT  LOD ZIMMER SURGICAL, INC. N/A 63077590

    Patients

    Seq Age Sex Outcome Treatment
    1