BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HD 12/14 +4MM NK 28MM MSL

    MDR report key: 7371752 · Received March 26, 2018

    Report

    Report Number
    0001822565-2018-01664
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    November 2, 2004
    Report Date
    April 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK123019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 4245, CUP, LOT # 2214665; ITEM # 0100010409, LINER, LOT # 2212386; ITEM # 290039100, FEMORAL STEM, LOT # 2218074. (B)(6).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL: UPDATED REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. SURGERY NOTES, STATES ONE-STAGE REVISION OF LEFT THA DUE TO INFECTION. THE MANUFACTURING LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION.DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT REVISION DUE TO INFECTION APPROXIMATELY ONE MONTH POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212168 COCR HD 12/14 +4MM NK 28MM MSL HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 1601844

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R