BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS HA MODULAR REVISION SYSTEM CONE PROX BODY SIZE A HIGH OFFSET 70MM

    MDR report key: 6023677 · Received October 12, 2016

    Report

    Report Number
    0001825034-2016-04087
    Event Type
    Injury
    Date Received
    October 12, 2016
    Report Date
    July 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER STATES "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET IN (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K090757. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - NI. THIS REPORT IS NUMBER 3 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04055 / 04056, & 04106, 3002806535-2016-00784 / 00785).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCT: ARCOS 18 X 250 MM INTERLOCKING DISTAL STEM, CATALOG #22-301918 LOT 251730. ARCOS DISTAL SCREW TI 5 X 45 MM, CATALOG #166069 LOT #1829580. ARCOS DISTAL SCREW TI 5 X 50 MM, CATALOG #166070 LOT #1829586. DEVICES WERE NOT RETURNED SO PRODUCT EVALUATION COULD BE CONDUCTED. THE DEVICES WERE USED FOR TREATMENT. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORIES DETERMINED NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED INFECTION FOLLOWING IMPLANTATION OF A HIP PROSTHESIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671966 ARCOS HA MODULAR REVISION SYSTEM CONE PROX BODY SIZE A HIGH OFFSET 70MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 915820

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention