BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS MODULAR REVISION HIP SYSTEM STANDARD BROACH PROXIMAL BODY

    MDR report key: 6230376 · Received January 6, 2017

    Report

    Report Number
    0001825034-2016-05457
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    December 8, 2016
    Report Date
    July 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PNOT CLEARED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 OR DEVIATION. (B)(4). THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED AT ZIMMER BIOMET IN THE U.S. UNDER 510K NUMBER K090757.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE WAS USED FOR TREATMENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED APPROXIMATELY 5 MONTHS POST-IMPLANTATION DUE TO SUBSIDENCE OF THE FEMORAL COMPONENTS. DURING THE REVISION, THE FEMORAL HEAD AND STEM WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14487 ARCOS MODULAR REVISION HIP SYSTEM STANDARD BROACH PROXIMAL BODY PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 259280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R