BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET SPLINED KNEE STEM WITH SCREW 18MM X 80MM

    MDR report key: 7915113 · Received September 27, 2018

    Report

    Report Number
    0001825034-2018-09206
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    August 23, 2017
    Report Date
    September 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK121149
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET OFFSET TIBIAL TRAY ADAPTOR, CATALOG #: 141491, LOT #: 149400, BIOMET OFFSET TIBIAL TRAY 74MM, CATALOG #: 141484, LOT #: 212390. THE RETURNED STEM AND OFFSET ADAPTOR WERE EVALUATED AND THE REPORTED DISASSEMBLY WAS CONFIRMED, HOWEVER, THE SEATING ISSUE WAS NOT VERIFIABLE AS NOT ALL COMPONENTS WERE RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICES NOTED SCRATCHES AND OTHER MARKINGS CONSISTENT WITH BEING EXPLANTED AND THEN REMOVED FROM THE TIBIAL TRAY AS REPORTED. DIMENSIONAL ANALYSIS OF THE GAP BETWEEN THE OFFSET ADAPTOR AND THE STEM DETERMINED THAT THE GAP IS LARGER THAN EXPECTED, INDICATING THAT THE COMPONENTS MAY NOT HAVE BEEN FULLY MATED DURING ASSEMBLY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ALL REPORTS ASSOCIATED: 0001825034-2017-07109; 0001825034-2018-09209.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OFFSET ADAPTER, STEM AND TIBIAL TRAY WERE NOTED TO NOT BE PROPERLY ASSEMBLED DURING KNEE ARTHROPLASTY, RESULTING IN DIFFICULTY SEATING THE DEVICES. THE SURGEON REMOVED THE SCREW AND THE OFFSET ADAPTER WAS THEN DISASSEMBLED FROM THE TIBIAL TRAY, AT WHICH TIME THE OFFSET ADAPTER WAS FOUND TO BE DAMAGED. A REPLACEMENT PART WAS UNAVAILABLE, SO THE SURGEON RE-TRIALED USING A DIFFERENT SIZE. THE CONSTRUCT STILL WOULD NOT FULLY SEAT, SO THE SURGEON REMOVED THE POLYETHYLENE PLUG FROM THE AUGMENT HOLES. THE IMPLANTS WERE THEN ABLE TO BE SEATED SUCCESSFULLY AND THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757452 BIOMET SPLINED KNEE STEM WITH SCREW 18MM X 80MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 169810

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR