BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA NATURAL TIBIA CEMENTED STEMMED

    MDR report key: 8086682 · Received November 19, 2018

    Report

    Report Number
    0002648920-2018-00833
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    October 29, 2018
    Report Date
    October 25, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    K113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: HI-FATIGUE BONE CEMENT 1X40 G CATALOG # 00-1121-140-01 LOT # 81464445 QTY 2. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PATIENT¿S MEDICAL RECORDS. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION.  ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MEDICAL RECORDS WERE REVIEWED BY A HEALTH CARE PROFESSIONAL AND CONFIRM THE ISSUE OF LOOSENING. THE PATIENT WAS EXPERIENCING PAIN, SWELLING, AND LOOSENING APPROXIMATELY 3 YEARS POST IMPLANTATION. 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

    FROM ADDITIONAL INFORMATION RECEIVED IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL PROSTHESIS, PAIN AND SWELLING.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE: 2015. CONCOMITANT MEDICAL PRODUCTS: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 6, CATALOG # 42500606002, LOT # 62682121. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 20 MM HEIGHT, CATALOG # 42521400720 ,LOT # 62754874. HI-FATIGUE BONE CEMENT 1X40 G, CATALOG # 00-1121-140-01, LOT # 61464445, QTY.: 2. THIS BONE CEMENT IS MANUFACTURED AT (B)(4) AND DISTRIBUTED THROUGH ZIMMER ORTHOPEDIC SURGICAL PRODUCTS. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE BONE CEMENT IS NOT MANUFACTURED AT HERAEUS MEDICAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS REVISED DUE TO PAIN. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924286 PERSONA NATURAL TIBIA CEMENTED STEMMED PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 63106017

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R