BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC STEM

    MDR report key: 6725130 · Received July 19, 2017

    Report

    Report Number
    0001825034-2017-05045
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    June 22, 2017
    Report Date
    October 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK091508
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K101086.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ONE MONTH POST IMPLANTATION PATIENT FELL AND WAS REVISED ON UNKNOWN DATE (B)(6) 2017. HOWEVER IT IS UNKNOWN THAT THE PATIENT FALL IS DUE TO ZB IMPLANTS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. 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

    IT WAS REPORTED ONE MONTH POST-IMPLANTATION PATIENT FELL DURING REHAB AND FRACTURED AROUND THE STEM. THE STEM WAS REMOVED AND REPLACED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506410 TAPERLOC STEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 3863321

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R