BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PATELLA 28 3 PEG

    MDR report key: 6869484 · Received September 15, 2017

    Report

    Report Number
    0001825034-2017-07111
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    March 13, 2015
    Report Date
    November 10, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR¿S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-04728, 0001825034-2017- 07111. CONCOMITANT PRODUCT(S): - P/N EP-183624 E1 VNGD PS TIB BRG 63/67X14. P/N 184762 SERIES A PAT STD 28 3 PEG. P/N 183104 VNGD PS OPEN INTL FEM RT 60. P/N 141232 BIOMET CC CRUCIATE TRAY 67MM. FOREIGN SOURCE- (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ENROLLED IN A CLINICAL STUDY AND UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY TEN MONTHS POST-IMPLANTATION DUE TO PATELLAR DISLOCATION AND INSTABILITY. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A FALL. ALL COMPONENTS WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649599 SERIES A PATELLA 28 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R