BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GENDER SPECIFIC POROUS FEMORAL COMPONENT

    MDR report key: 6174534 · Received December 14, 2016

    Report

    Report Number
    0001822565-2016-04627
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 14, 2016
    Report Date
    October 16, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK072619
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS 1 OF 3 FOR THIS PATIENT: 0001822565-2016-04626/0001822565-2016-04627/0001822565-2016-04628.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. CONCOMITANT MEDICAL PRODUCTS: FLUTED STEM MOBILE TIBIAL COMPONENT/PRECOAT LOT#62458012 ITEM#00594605001; PALACOS R+G 1X 40 LOT#77804354 ITEM#66022663; ARTICULAR SURFACE FOR EXPORT ONLY NOT FOR DISTRIBUTION IN THE USA SIZE E 10 MM HEIGHT LOT#62360641 ITEM#00594605010. THE REPORTED EVENT IS CONFIRMED AS THE X-RAYS PROVIDED IDENTIFIED RADIOLUCENCY. PRODUCT WAS NOT RETURNED. RADIOGRAPH REVIEW RELAYED, "THIN RADIOLUCENCIES AT FEMORAL COMPONENT METAL BONE INTERFACES APPEAR LESS THAN 2 MM IN WIDTH; HOWEVER, MAY BE OF CONCERN FOR LOOSENING OF THE FEMORAL COMPONENT IF NEW OR PROGRESSIVE SINCE EARLIER STUDIES." NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTION WAS NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING AFTER A KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825038 NEXGEN LPS-FLEX GENDER SPECIFIC POROUS FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. N/A 62252405

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 66022663, PALACOS R+G 1X40, LOT 77804354