BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS CEMENTED FEMORAL

    MDR report key: 6503270 · Received April 19, 2017

    Report

    Report Number
    3007963827-2017-00212
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    March 9, 2017
    Report Date
    October 4, 2017
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    NJL
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE, CATALOG #: 00596204012, LOT #: UNKNOWN. NEXGEN STEMMED PRECOAT TIBIAL COMPONENT, CATALOG #: 00598004702, LOT #: 62383338. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P060037. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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: 0001822565-2017-02339 AND 0002648920-2017-00243.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, THIS DEVICE IS NOT REPORTABLE AS IT IS NOT RELATED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286405 NEXGEN LPS CEMENTED FEMORAL PROSTHESIS, KNEE NJL ZIMMER ORTHOPAEDIC MFG. LTD. 62372221

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R