BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA FEMUR CEMENTED POSTERIOR STABILIZED

    MDR report key: 9356410 · Received November 21, 2019

    Report

    Report Number
    3007963827-2019-00327
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    November 1, 2019
    Report Date
    March 13, 2020
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    K113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT IS A DUPLICATE REPORTING AND THIS REPORT WILL BE VOIDED. THEREFORE ANY FURTHER REPORTING WILL BE UNDER THIS MFR NUMBER 3007963827 - 2019 - 00342 - 1. 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

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT IS A DUPLICATE REPORTING AND THIS REPORT WILL BE VOIDED. THEREFORE ANY FURTHER REPORTING WILL BE UNDER THIS MFR NUMBER 3007963827 - 2019 - 00342 - 1.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). UDI: (B)(4). MEDICAL PRODUCTS: ARTICULAR SURFACE; P/N: 42511401014, L/N: 64090617, FEMUR CEMENTED; P/N: 42500607001, L/N: 64105209, ALL POLY PATELLA; P/N: 42540000038, L/N: 64342511, NATURAL TIBIA TRABECULAR; P/N: 42530007901, L/N: 64140981. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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: 3007963827 - 2019 - 00326, 0002648920 - 2019 - 00851, 0001822565 - 2019 - 04962. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION PROCEDURE 2 MONTHS POST-IMPLANTATION DUE TO INFECTION. SUBSEQUENTLY, ALL THE COMPONENTS WERE REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151257 PERSONA FEMUR CEMENTED POSTERIOR STABILIZED PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64105209

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R