BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMORIS HIP STEM

    MDR report key: 5851617 · Received August 5, 2016

    Report

    Report Number
    3002806535-2016-00671
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    September 22, 2015
    Report Date
    February 15, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K050441. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS REPORT IS NUMBER 4 OF 4 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00668 / 00671). DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K050441.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 THAT PATIENT ENROLLED IN A CLINICAL STUDY FOR THE LEFT SIDE AND EXPERIENCED UNKNOWN COMPLICATIONS APPROXIMATELY FIVE MONTHS POST-IMPLANTATION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY FOR THE LEFT SIDE AND EXPERIENCED PAIN AND REDUCE MOBILITY APPROXIMATELY FIVE MONTHS POST-IMPLANTATION. PATIENT UNDERWENT SYNOVECTOMY AS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501974 PRIMORIS HIP STEM PROSTHESIS, HIP JDI BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention