BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP RESURFACING FEMORAL HEAD

    MDR report key: 7198796 · Received January 17, 2018

    Report

    Report Number
    0001825034-2018-00244
    Event Type
    Injury
    Date Received
    January 17, 2018
    Report Date
    March 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KXA
    PMA / PMN Number
    PK023188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED FROM MEDICAL RECORDS RECEIVED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL RETURN TO ZIMMER BIOMET FOR INVESTIGATION, ONCE THE REVISION HAS TAKEN PLACE, AS IT CURRENTLY REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: US157854, CUP, LOT # 210300. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2018-00244, 00245.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING UNEXPLAINED PAIN, LIMPING, AND DISCOMFORT FOLLOWING RIGHT HIP ARTHROPLASTY. A REVISION PROCEDURE HAS BEEN INDICATED; HOWEVER, NO PROCEDURE HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING UNEXPLAINED PAIN WITH HER RIGHT HIP REPLACEMENT. A REVISION PROCEDURE HAS BEEN INDICATED; HOWEVER, NO PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45029 RECAP RESURFACING FEMORAL HEAD PROSTHESIS, HIP KXA ZIMMER BIOMET, INC. N/A 535430 

    Patients

    Seq Age Sex Outcome Treatment
    1 Other