BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN LPS-FLEX PS TIBIAL TRAY

    MDR report key: 14632568 · Received June 8, 2022

    Report

    Report Number
    0001822565-2022-01725
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    June 12, 2021
    Report Date
    July 13, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-01724. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN NEXGEN FEMORAL CATALOG#: NI, LOT#: NI, UNKNOWN ARTICULAR SURFACE CATALOG#: NI, LOT#: NI. REPORT SOURCE: FOREIGN SOURCE: ITALY. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CITATION: RISSOLIO, L.; SABATINI, L.; RISITANO, S.; BISTOLFI, A.; GALLUZZO, U.; MASSÈ, A.; INDELLI, P.F. IS IT THE SURGEON, THE PATIENT, OR THE DEVICE? A COMPREHENSIVE CLINICAL AND RADIOLOGICAL EVALUATION OF FACTORS INFLUENCING PATIENT SATISFACTION IN 648 TOTAL KNEE ARTHROPLASTIES. J. CLIN. MED. 2021, 10, 2599. HTTPS://DOI.ORG/10.3390/JCM10122599.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, G3, G6, H2, H3, H6, AND H10. PATIENT INFO FROM STUDY: GENDER: 9 FEMALE AND 3 MALE. DATE OF BIRTH & AGE: FROM 58 TO 78 YO. AVG: 68.25 YO (AT THE MOMENT OF SURGERY). D6A IMPLANT DATE: THE INITIAL KNEE ARTHROPLASTIES WERE ALL PERFORMED BETWEEN 2013 AND 2016. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA STUDY THAT 12 PATIENTS UNDERWENT A REVISION DUE TO ASEPTIC LOOSENING FOLLOWING KNEE ARTHROPLASTIES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12381 UNKNOWN NEXGEN LPS-FLEX PS TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R