BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-POLAR 28 CUP 47MM

    MDR report key: 11751536 · Received April 30, 2021

    Report

    Report Number
    3002806535-2021-00145
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 5, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    05019279403271
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS FOUND NO OTHER SIMILAR COMPLAINTS FOR ITEM (B)(4). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. THE RISK ASSOCIATE WITH THE REPORTED IS ADDRESSED IN BI-POLAR HEADS RISK MANAGEMENT REPORT. THE SEVERITY OF THE REPORTED EVENT IS IN LINE WITH THE RISK FILE, AND NO ISSUE WITH THE OCCURRENCE RATE HAS BEEN IDENTIFIED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INITIAL SURGERY TO REDUCE THE HIP JOINT, THE BI POLAR CUP DISASSEMBLED SPONTANEOUSLY RESULTING WITH NO HEALTH CONSEQUENCES AS THE OPERATION WAS COMPLETED WITH ANOTHER IMPLANT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ASSOCIATED PRODUCTS : MEDICAL PRODUCT: TAPERLOC PC 6.0 MM 12/14, CATALOG : 650-0580, LOT : 6926127. MEDICAL PRODUCT: BI POLAR 28 CUP 47MM, CATALOG : 165218, LOT : 6638865. MEDICAL PRODUCT: COCR HD SHT NK 28 -3.5MM 12/14, CATALOG : P0206C28, LOT : J6870780. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL SURGERY TO REDUCE THE HIP JOINT THE BI POLAR CUP DISASSEMBLED SPONTANEOUSLY RESULTING WITH NO HEALTH CONSEQUENCES AS THE OPERATION WAS COMPLETED WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654732 BI-POLAR 28 CUP 47MM HIP ARTHROPLASTY LZO BIOMET UK LTD. N/A 6739647 05019279403271

    Patients

    Seq Age Sex Outcome Treatment
    1