BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RS SIDE EXP DSTL FMRL LT 15CM

    MDR report key: 9717732 · Received February 17, 2020

    Report

    Report Number
    0001825034-2020-00745
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 24, 2020
    Report Date
    April 29, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K140509
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: (B)(6) 2020, 150478 OSS POLY LOCK PIN 104760, 150493 OSS REINFORCED YOKE 888420, 888420 OSS RS AXLE 552090, 161034 OSS RS POLY FEM BUSHINGS SET/2 155730, 150476 OSS POLY TIBIAL BUSHING 850230, 161040 OSS RS NON-MOD PLT SHRT 71 826540, 178512 CPS NUT CO-CR-MO ALLOY 484110, 178538 CPS CENTERING SLEEVE 16MM 548010, 178351 CPS XS SPDL WITH PINS 600LBF 498540, 178526 CPS TRANSVERSE PIN 6PK 28MM 787280, 178404 CPS ANCHOR PLUG 14MM 332040, 161095 OSS RS 14MM LS TIBIAL BEARING 729400. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL RIGHT OSS KNEE ARTHROPLASTY. APPROXIMATELY 22 MONTHS POST IMPLANTATION, THERE WAS DIFFICULTY DURING THE LENGTHENING PROCESS OF THE OSS FEMUR, IN WHICH THE FEMUR COULD NOT BE EXPANDED. THERE HAS BEEN NO REVISION REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181457 RS SIDE EXP DSTL FMRL LT 15CM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 252430

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR