BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER 26 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS

    MDR report key: 6139639 · Received December 1, 2016

    Report

    Report Number
    0002648920-2016-03317
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    October 31, 2016
    Report Date
    September 19, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    PMA / PMN Number
    PK833991
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE LOCKING RING WAS POSITIONED INSIDE THE LINER AS DESIGNED. NEITHER THE LINER OR LOCKING RING SHOWS SIGNS OF DAMAGE OR WEAR THAT WOULD INDICATE AN ATTEMPT TO IMPLANT WAS MADE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND DISASSEMBLED AT THE TIME OF OPENING. THE SURGERY WAS FINISHED WITH ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788572 LINER 26 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. N/A 63134043

    Patients

    Seq Age Sex Outcome Treatment
    1