BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT SIZE G RIGHT

    MDR report key: 6460092 · Received April 5, 2017

    Report

    Report Number
    3007963827-2017-00209
    Event Type
    Injury
    Date Received
    April 5, 2017
    Date of Event
    July 19, 2016
    Report Date
    December 7, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT- NEXGEN PRECOAT STEMMED TIBIAL PLATE, CATALOG #: 00598005701, LOT #: 61916238. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET LTD, (B)(4) AND IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P060037/S046 . 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: 0002648920-2017-00220.

    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. MEDICAL PRODUCTS- NEXGEN LPS-FLEX FEMORAL COMPONENT OPTION CATALOG# 00-5964-017-52 LOT# 61849036, NEXGEN STEMMED TIBIAL COMPONENT CATALOG# 00-5980-057-01 LOT# 61916238, NEXGEN LPS-FLEX ARTICULAR SURFACE CATALOG# 00-5962-050-14 LOT# 61233328, NEXGEN ALL POLY PATELLA CATALOG# 00-5972-066-38 LOT# 61733263.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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 AS NO TRENDS WERE IDENTIFIED. THE ROOT CAUSE CANNOT BE DETERMINED USING PROVIDED INFORMATION. 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 WAS REPORTED THAT FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO AN UNKNOWN REASON. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO AN INFECTION AND LOOSENING OF COMPONENTS. OPERATIVE NOTES INDICATED THE BONE UNDERLYING THE FEMORAL AND TIBIAL PROSTHESIS WAS SOFT, PARTICULARLY ON THE LATERAL SIDE. THERE WAS ALSO A COPIOUS AMOUNTS OF FLUID, TISSUE, BONE CULTURE, AND GRAM STAINED FROM THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241889 NEXGEN LPS-FLEX FEMORAL COMPONENT SIZE G RIGHT PROSTHESIS, KNEE NJL ZIMMER ORTHOPAEDIC MFG. LTD. 61849036

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R