BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMEDULLARY PLUG XL

    MDR report key: 19712023 · Received July 10, 2024

    Report

    Report Number
    0001825034-2024-01818
    Event Type
    Injury
    Date Received
    July 10, 2024
    Report Date
    October 22, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDS
    UDI-DI
    00880304227354
    PMA / PMN Number
    K800144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, G3, G6, H2, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND COVER THE LINKED COMPLAINTS, THE PLUG HAS BEEN RETAINED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UNABLE TO CONFIRM SPECIFIC ISSUES WITH THE PLUG. 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 · 0

    (B)(4). D10: 183302 ITEM NAME VNGD SSK PSC INTLK FMRL 60 RT LOT # 605140. 183824 ITEM NAME VNGD SSKPSC TIB BRG S 14X63/67 LOT # 636650. 185201 ITEM NAME BMT 360 TIB TRAY 63MM LOT # 897880. 148162 ITEM NAME BMT GB KNEE STM 12X80 LOT # 153050. 00585204025 ITEM NAME STEM COLLAR 25 MM LOT # 64243673. 00542000800 ITEM NAME ALL POLY PATELLA SIZE 0 8 MM THICKNESS LOT # 64212622. 5036964 ITEM NAME ¿ HERAEUS MEDICAL CEMENT W/GENT HIGH VISCOCITY LOT # 93564861. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172313 INTRAMEDULLARY PLUG XL PROSTHETIC, HIP JDS ZIMMER BIOMET, INC. N/A 685630 00880304227354

    Patients

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