BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDUCED SIZE SCREW EXPANDABLE

    MDR report key: 7281955 · Received February 20, 2018

    Report

    Report Number
    0001825034-2018-00836
    Event Type
    Injury
    Date Received
    February 20, 2018
    Report Date
    March 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK043547
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 178552 CPS SHORT ANCHOR PLUG 10MM 547460, 178526 CPS TRANSVERSE PIN 6PK 28MM 171080, 178525 CPS TRANSVERSE PIN 6PK 24MM 682910, CP111814 RED SEXP DSTL FEM 16CM RT ASSY 185340 , 161034 OSS RS POLY FEM BUSHINGS SET/2 688380, 161094 OSS RS 12MM LS TIBIAL BEARING 466450, 178362 CPS XS SHT SPDL W PINS 400LBF 410380, 178512 CPS NUT CO-CR-MO ALLOY 217560, 161016 OSS RS NON-MOD PLATE SHORT 51 957530, 150493 OSS REINFORCED YOKE 915780, 161035 OSS RS AXLE 625520, 150476 OSS POLY TIBIAL BUSHING 495710, 150478 OSS POLY LOCK PIN 259170. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT KNEE ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, THE SURGEON IS REQUESTING A DEVICE FOR A REVISION PROCEDURE OCCURING DUE TO UNKNOWN REASONS. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124889 REDUCED SIZE SCREW EXPANDABLE PROSTHESIS KNEE KWA ZIMMER BIOMET, INC. N/A 185340 

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention