BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER 26 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS

    MDR report key: 6139722 · Received December 1, 2016

    Report

    Report Number
    0002648920-2016-03319
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    October 26, 2016
    Report Date
    April 25, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. MEDICAL PRODUCT SHELL CATALOG#: 00500104500 LOT#: 63152863. A MULTIPOLAR BIPOLAR SHELL AND LINER WERE RETURNED FOR REVIEW. AS RETURNED, ONE TAB OF THE LOCK RING WAS SEIZED IN THE LOCK RING GROOVE. DAMAGE/GOUGES ARE SEEN ON THE MATING SURFACE OF THE POLY LINER. THIS DAMAGE APPEARS TO BE WITNESS MARKS FROM THE LOCK RING, INDICATING THAT THE RING WAS SEIZED DURING THE INITIAL ATTEMPT TO INSTALL. THE INTERFACING DIAMETERS OF BOTH DEVICES AND THE LOCK RING GROOVE ARE FOUND TO BE CONFORMING TO PRINT SPECIFICATIONS. AFTER THE LOCK RING WAS REMOVED FROM THE SHELL DAMAGE WAS SEEN ON THE SEIZED TAB. DIMENSIONAL MEASUREMENTS OF THE LOCK RING ARE CONFORMING TO PRINT SPECIFICATIONS. THE LOCK RING AND LINER WERE REINSTALLED IN THE SHELL, SEATING/FUNCTIONING AS INTENDED. 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

    UDI: (B)(4). 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. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0002648920-2016-03319).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER COULDN'T BE ASSEMBLED TO THE CUP. THE SURGERY WAS FINISHED WITH ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789932 LINER 26 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. N/A 63435179

    Patients

    Seq Age Sex Outcome Treatment
    1