BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMET ARCOM AP PAT W/WIRE 31MM IRE 31MM

    MDR report key: 14286701 · Received May 5, 2022

    Report

    Report Number
    0001825034-2022-01116
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    November 21, 2011
    Report Date
    June 2, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K945028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCT:   VNGD CR TIB BRG 10X63/67 MM: CATALOG#183420, LOT#360020;   BIOMET FINNED PRI STEM 40MM: CATALOG#141314, LOT#854950; BIOMET ILOK PRI TIB TRAY 63MM: CATALOG#141211, LOT#621150;  VANGUARD CR INTERLOK FEM - RT 60: CATALOG#183004, LOT#901300. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01115; 0001825034-2022-01117; 0001825034-2022-01118 AND 0001825034-2022-01119. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR EVALUATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES PAIN IN GROIN AND BUTTOCKS, FEELING OF INSTABILITY, VALGUS INSTABILITY AS REPORTED. ROOT CAUSE WAS UNABLE TO 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 AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT STATES TO HAVE PERSISTENT PAIN FOR THE PAST TEN YEARS AND FIVE MONTHS POST IMPLANTATION. THE PATIENT ALSO EXPERIENCES SWELLING IN THE KNEE WITH WEATHER CHANGES AND STATES THAT THE LEFT LEG HAS BEEN LONGER THAN THE RIGHT SINCE THE SURGERY. INSTABILITY WAS NOTED UPON ASSESSMENT AND THE PATIENT UNDERWENT BONE SCANS AND LAB WORK TO DETERMINE ELIGIBILITY FOR REVISION. FINAL OUTCOME IS PENDING AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569138 BMET ARCOM AP PAT W/WIRE 31MM IRE 31MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. 867610

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other