BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN DROP DOWN STEM EXTENSION 45 MM LENGTH

    MDR report key: 6660196 · Received June 22, 2017

    Report

    Report Number
    0001822565-2017-04266
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    December 11, 2014
    Report Date
    October 24, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK043101
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS NOT INDICATED WHETHER OR NOT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. IF PRODUCT IS RECEIVED FOR EVALUATION, A FOLLOW-UP MDR WILL BE SUBMITTED WITH ANY NEW INFORMATION RECEIVED. CONCOMITANT MEDICAL PRODUCT: ZIMMER NEXGEN MIS PRECOAT STEMMED TIBIAL COMPONENT CATALOG # 00-5950-047-01 LOT # 60336057. PALACOS REFOBACIN 1X40 BONE CEMENT CATALOG # 00-1112-140-01 LOT # 63273894. ZIMMER NEXGEN STANDARD ALL POLYETHYLENE PATELLA 32MMX8.5MM CATALOG # 00-5972-065-32 LOT # 60307309. ZIMMER NEXGEN LPS-HIGH FLEX FIXED ARTICULAR SURFACE SIZE EF 5-6 14MM CATALOG # 00-5964-040-14 LOT # 60248601. ZIMMER NEXGEN LPS-HIGH FLEX PRECOAT FEMORAL SIZE F LEFT CATALOG # 00-5960-016-51 LOT # 60360313. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES PROVIDED. REVIEW OF THE INITIAL SURGERY OPERATION NOTES REVEALED NO DEVIATIONS IN THE SURGICAL TECHNIQUE. THE REVISION SURGERY OPERATIVE NOTES REVEALED "LOOSE TIBIAL COMPONENT, WITH UNDERLYING FIBROUS TISSUE CONSISTENT WITH OSTEOLYSIS. POOR BONE QUALITY ON LATERAL TIBIAL PLATEAU. PITTING AND WEAR OF THE TIBIAL POLYETHYLENE INSERT. FIBROUS CYSTS UNDERMINING PATELLA COMPONENT CONSISTENT WITH OSTEOLYSIS AND NO GROSS EVIDENCE OF INFECTION." DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 001822565-2016-01270, 0001822565-2016-03906, 0002648920-2017-00251, 0001822565-2017-02719.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 A PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY, AND SUBSEQUENTLY WAS REVISED DUE TO TIBIAL LOOSENING, CYSTS, OSTEOLYSIS, AND WEAR OF THE POLYETHYLENE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441768 NEXGEN DROP DOWN STEM EXTENSION 45 MM LENGTH PROSTHESIS, KNEE JWH ZIMMER, INC. N/A 60452416

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R