BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL SHELL WITH CLUSTER HOLES

    MDR report key: 5347853 · Received January 6, 2016

    Report

    Report Number
    1822565-2016-00014
    Event Type
    Injury
    Date Received
    January 6, 2016
    Report Date
    December 10, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: CATALOG #00630505840, ZIMMER TRILOGY ACETABULAR LINER, LOT #61258654; THE FOLLOWING PRODUCTS WERE MANUFACTURED BY ZIMMER B.V., PONCE, PR: CATALOG #00625006535, ZIMMER SELF-TAPPING BONE SCREW, LOT #61283942. CATALOG #00625006525, ZIMMER SELF-TAPPING BONE SCREW, LOT #61313558. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE RELATED LOTS AND WERE FOUND TO BE CONFORMING. NO PRODUCT WAS RETURNED AS THESE REMAIN IMPLANTED THEREFORE THE CONDITION OF THE IMPLANTS ARE UNKNOWN. THESE DEVICES ARE USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO ADDITIONAL COMPLAINTS FOR THE PART-LOT COMBINATIONS, APART FROM THOSE ASSOCIATED WITH THIS PATIENT. A REVIEW OF THE PROGRESS NOTES FOUND THAT IT WAS 10 DAYS POST SURGERY THAT 3 OUT OF 4 TISSUE SPECIMENS REVEALED PROPIONIBACTERIUM ACNES. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10^-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICES CAUSED ANY PATIENT INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT IS EXPERIENCING SIGNIFICANT PROPIONIBACTERIUM ACNES INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7926 TRABECULAR METAL SHELL WITH CLUSTER HOLES JDI JDI ZIMMER INC 61120973

    Patients

    Seq Age Sex Outcome Treatment
    1 Other