BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SEGMENTAL STEM COLLAR 25 MM O.D. FOR USE WITH 16 MM

    MDR report key: 19565963 · Received June 19, 2024

    Report

    Report Number
    0001822565-2024-02029
    Event Type
    Injury
    Date Received
    June 19, 2024
    Report Date
    November 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00889024197633
    PMA / PMN Number
    K070978
    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: 00542000800 - ALL POLY PATELLA SIZE 0 8 MM THICKNESS - 64212622 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. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. H6 : PROPOSED COMPONENT CODE: MECHANICAL (G04) STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THE STEM AND THE REPORTED PART AND LOT COMBINATION. OFFICE NOTES POST-SURGERY STATE PATIENT STILL HAS PAIN, SWELLING AND RANGE OF MOTION ISSUES. PATIENT IS ALSO EXPERIENCING KNEE WEAKNESS WHICH HAS LIMITED HER FUNCTIONAL MOBILITY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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
    625441 ZIMMER SEGMENTAL STEM COLLAR 25 MM O.D. FOR USE WITH 16 MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 64243673 00889024197633

    Patients

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