BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER LONGEVITY HIGLY CROSSLINKED POLYETHYLENE LINER

    MDR report key: 6055038 · Received October 25, 2016

    Report

    Report Number
    0001822565-2016-03713
    Event Type
    Injury
    Date Received
    October 25, 2016
    Date of Event
    September 15, 2016
    Report Date
    March 22, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICES IS UNKNOWN. THE DEVICES WERE USED IN AN APPROVED AND COMPATIBLE COMBINATION. DEVICE HISTORY RECORD REVIEW IDENTIFIED NO DEVIATIONS OR ANOMALIES IN THE MANUFACTURING PROCESS FOR LOTS 62565781, 61540018, 62690198. DHR REVIEW OF LOT 62700916 SHOWS NO DEVIATIONS TO THE STANDARD MANUFACTURING PROCESS THAT WOULD HAVE AFFECTED THE SURGICAL OUTCOME OR CONTRIBUTED TO THE REPORTED EVENT OF INFECTION. (B)(4) WERE WRITTEN FOR NONCONFORMING TAPERS UNRELATED TO THE REPORTED ISSUE. THREE PIECES WERE SCRAPPED AND REMOVED FROM THE LOT. LOT 62775767 HAD A PLANNED DEVIATION FOR PRODUCT PROCESSED AFTER EXECUTION OF PREVENTIVE MAINTENANCE ON RO WATER SYSTEM FOLLOWING SPECIAL MAINTENANCE REQUEST. REVIEW OF THE DHR CONFIRMED THAT THE DEVICES WERE STERILIZED PRIOR TO RELEASE. THE DEVICES WERE USED FOR TREATMENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO PREVIOUS COMPLAINTS FOR THE PART-LOT COMBINATION OF THE REPORTED DEVICES. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. 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 OR CONTRIBUTED TO PATIENT INFECTION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT HAD A PIC LINE FOR 6 WEEKS AFTER SPACER IMPLANTED IN (B)(6). THE PATIENT THEN UNDERWENT AN ASPIRATION IN SEPTEMBER AND IS CURRENTLY AWAITING IMPLANTATION OF FINAL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704946 ZIMMER LONGEVITY HIGLY CROSSLINKED POLYETHYLENE LINER HIP PROSTHESIS LPH ZIMMER, INC. 61540018

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R