BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SEGMENTAL SYSTEM - FLUTED STEM EXTENSION 12 MM DIAMETER 130 MM LENGTH

    MDR report key: 6609017 · Received June 2, 2017

    Report

    Report Number
    0001822565-2017-03800
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    June 22, 2017
    Report Date
    February 21, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK070978
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND.THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. MULTIPLE MDR SUPPLEMENTAL REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2017-00373-1, 1822565-2017-03798-1, 1822565-2017-03799-1, 1822565-2017-03801-1, AND 1822565-2017-03802-1.

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT PRODUCTS ¿ ROTATING HINGE TIBIAL PLATE CATALOG 00588000200 LOT 62403260; NEXGEN STEMS CATALOG 00598801813 LOT 63076396; TIBIAL AUGMENT BLOCK CATALOG 00588000210 LOT 62038651; DISTAL FEMORAL COMPONENT SIZE B RIGHT CATALOG 00585001202 LOT 62792972; ARTICULAR SURFACE WITH SEGMENTAL HINGE POST CATALOG 00585002012 LOT 63203039; POLYETHYLENE INSERT SIZE B CATALOG 00585001295 LOT 63240982; TRABECULAR METAL FEMORAL DIAPHYSEAL CONE CATALOG 00545001731 LOT 63177170; TRABECULAR METAL TIBIAL CONE CATALOG 00545001336 LOT 63205327; CERAMENT BONE VOID FILLER CATALOG 800-4002 LOT 0277; CERAMENT BONE VOID FILLER CATALOG 800-4001 LOT 0255. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 1822565-2017-03797, 0002648920-2017-00373, 1822565-2017-03798, 1822565-2017-03799, 1822565-2017-03801, AND 1822565-2017-03802.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SIXTEEN MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE FEMORAL COMPONENT. THE FEMORAL COMPONENT, ARTICULAR SURFACE AND POLYETHYLENE INSERT WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR A RIGHT KNEE REVISION PROCEDURE DUE TO LOOSENING. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389257 ZIMMER SEGMENTAL SYSTEM - FLUTED STEM EXTENSION 12 MM DIAMETER 130 MM LENGTH PROSTHESIS, KNEE KRO ZIMMER, INC. 62575891

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention