BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMAX CERAMIC INSERT 36 X 58

    MDR report key: 10251901 · Received July 9, 2020

    Report

    Report Number
    1818910-2020-15408
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 26, 2020
    Report Date
    June 26, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MRA
    UDI-DI
    10603295012542
    PMA / PMN Number
    K000306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4) INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED LINER CONFIRMS THE REPORTED MATERIAL FRACTURE. THE ROOT CAUSE IS ATTRIBUTED TO INADVERTENT USE ERROR. NO MANUFACTURING OR MATERIAL PROBLEM IDENTIFIED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: PRODUCT CODE 121887658, WORK ORDER 9268477 WAS MANUFACTURED ON 11-SEP-2019. 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. DEVICE HISTORY REVIEW: PRODUCT CODE 121887658, WORK ORDER 9268477 WAS MANUFACTURED ON 11-SEP-2019. 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CERAMAX CERAMIC ACETABULAR LINER CRACKED IN MULTIPLE PIECES AFTER IMPACTING INTO ACETABULAR SHELL. LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715358 CERAMAX CERAMIC INSERT 36 X 58 PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS MRA DEPUY ORTHOPAEDICS INC US 1218-87-658 9268477 10603295012542

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR