BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS CENTERING SLEEVE 18MM

    MDR report key: 11752734 · Received April 30, 2021

    Report

    Report Number
    0001825034-2021-01304
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304260658
    PMA / PMN Number
    K043547
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 178558 - CPS SHORT ANCHOR PLUG - 671340, 178528 - CPS TRANSVERSE PIN - 097450, 178367 - CPS SM SHT SPDL W PINS - 905950, 178512 - CPS NUT CO-CR-MO ALLOY - 099480, 150410 - OSS TIBIAL POLY BEARING - 002730, 150478 - OSS POLY LOCK PIN - 772830, 150417 - OSS NON-MOD TIB PLATE SHORT 67 - 761070, 178715 - CPS 8.5CM SEG FM OSS TPR LT - 507400, 150476 - OSS POLY TIBIAL BUSHING - 416430, 150493 - OSS REINFORCED YOKE - 666210, 150477 - OSS POLY FEMORAL BUSHINGS - 915230, 150480 - OSS AXLE - 942460. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS NOT RETURNED BY THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01301, 0001825034-2021-01302, 0001825034-2021-01303, 0001825034-2021-01305.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION APPROXIMATELY 18 MONTHS POST IMPLANTATION DUE TO A BROKEN COMPRESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653929 CPS CENTERING SLEEVE 18MM PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 527300 00880304260658

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.