BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENDER SOLUTIONS ALL POLY PATELLA SIZE 0 8 MM THICKNESS

    MDR report key: 19563262 · Received June 18, 2024

    Report

    Report Number
    0001822565-2024-02030
    Event Type
    Injury
    Date Received
    June 18, 2024
    Report Date
    November 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024189584
    PMA / PMN Number
    K173057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00585204025 - STEM COLLAR 25 MM O.D. FOR USE WITH 16 MM OR SMALLER DIAMETER SEGMENTAL STEMS - 64243673 5036964 - HERAEUS MEDICAL CEMENT W/GENT HIGH VISCOCITY - 93564861 183302 - VNGD SSK PSC INTLK FMRL 60 RT - 605140 183824 - VNGD SSKPSC TIB BRG S 14X63/67 - 636650 185201 - BMT 360 TIB TRAY 63MM - 897880 148162 - BMT GB KNEE STM 12X80 - 153050 130615 - INTRAMEDULLARY PLUG XL - 685630 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER: 0002648920-2024-00363. 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 THAT THE PATIENT UNDERWENT A KNEE SURGERY AND APPROXIMATELY 3 MONTHS POST-OP, THE PATIENT WAS DIAGNOSED WITH PATELLAR TENDONITIS AND RECEIVED A STEROID INJECTION. THE PATIENT CONTINUED TO HAVE ONGOING ISSUES WITH PAIN, SWELLING, QUADRICEP WEAKNESS/ATROPHY, BALANCE DEFICITS, AND LIMITED RANGE OF MOTION. ADDITIONAL COURSES OF PHYSICAL THERAPY WERE PRESCRIBED WITHOUT RESOLUTION. THE PATIENT DOES NOT WANT TO UNDERGO ANOTHER REVISION AND HAS CONTINUED TO SEEK HELP FOR ONGOING SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE 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
    783935 GENDER SOLUTIONS ALL POLY PATELLA SIZE 0 8 MM THICKNESS PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 64212622 00889024189584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11.