BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PALACOS CEMENT

    MDR report key: 6487357 · Received April 12, 2017

    Report

    Report Number
    0001822565-2017-02238
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    February 15, 2017
    Report Date
    October 31, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS COMPONENT WAS DETERMINED TO BE NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-01515 AND 0001825034-2017-01488. CONCOMITANT MEDICAL PRODUCTS - AGC PATELLA ARCOM POLY. WITH WIRE 31MM CATALOG #: 11-150826 LOT#: 676180 OR 509430, MAX ILK ANA RF PS FML 60LT VII CATALOG #: 145131 LOT #:390290, BIOMET CC I-BEAM TRAY 63MM CATALOG #: 141221 LOT#: 455570 OR 005430, AND MAX PS DCM TIB BRNG 10X63/67MM CATALOG# 11-146530 LOT# 900410. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWELVE YEARS POST-OP DUE TO PATIENT FALLING CAUSING THE PATIENT'S PATELLA TO FRACTURE AND THE CEMENT MANTEL TO BE DISRUPTED BETWEEN THE PATELLA POLYETHYLENE AND THE NATIVE BONE. THE POLYETHYLENE AND PATELLA WERE REMOVED AND REPLACED. IT WAS NOTED THERE AS NO SIGNS OF COMPONENT FAILURE OR EXCESSIVE WEAR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268727 UNKNOWN PALACOS CEMENT KRO ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R