BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA COMPONENT SIZE 3 RIGHT

    MDR report key: 7087849 · Received December 6, 2017

    Report

    Report Number
    0001822565-2017-08332
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    October 4, 2017
    Report Date
    January 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRR
    PMA / PMN Number
    K070695
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCTS WERE EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. PER THE GENDER SOLUTIONS PFJ PACKAGE INSERT, PAIN AND MALALIGNMENT ARE KNOWN POTENTIAL ADVERSE EFFECTS OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS- CONCOMITANT DEVICES - NEXGEN ALL POLY PATELLA SIZE 29MM CATALOG #: 00597206529 LOT #: 62413061. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT, PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001822565-2017-08332; 0002648920-2018-00768.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT IS NOT RETURNED TO ZIMMER BIOMET. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, A BURNING SENSATION AND IMPROPER SEATING OF THE PROSTHESES APPROXIMATELY FOUR YEARS POST-OPERATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT PARTIAL PATELLA FEMORAL PROCEDURE AND WAS REVISED DUE TO PAIN AND BURNING SENSATION. ALSO THE IMPLANT NOT SEATED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866222 GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA COMPONENT SIZE 3 RIGHT PROSTHESIS KNEE KRR ZIMMER BIOMET, INC. N/A 62314704

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R