BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HIP PROSTHESIS REVISION STEM

    MDR report key: 8665660 · Received June 4, 2019

    Report

    Report Number
    0009613350-2019-00352
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    April 11, 2019
    Report Date
    August 6, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ACCORDING TO THE ADDITIONAL INFORMATION AND DOCUMENTATION RECEIVED ON JULY 16, 2019 IT WAS DISCOVERED THAT THIS COMPLAINT (B)(4) IS A DUPLICATE OF THE ORIGINAL (B)(4) (SUBMITTED UNDER THE REFERENCES: 9613350 - 2015 - 01091 -2, 9613350-2015-01501-001, 9613350-2015-01501-002). ALL ADDITIONAL INFORMATION AND DOCUMENTATION RECEIVED ON JULY 16, 2019 WERE ALREADY AVAILABLE IN (B)(4). BOTH COMPLAINTS REPORT THE SAME ISSUE. FOR THIS REASON, THE EVENT WILL BE COVERED IN ORIGINAL COMPLAINT (B)(4) AND (B)(4) WILL BE SET TO "NOT A COMPLAINT". PLEASE VOID IT FROM YOUR DATABASE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE ADDITIONAL INFORMATION AND DOCUMENTATION RECEIVED ON JULY 16, 2019 IT WAS DISCOVERED THAT THIS COMPLAINT (B)(4) IS A DUPLICATE OF THE ORIGINAL (B)(4) (SUBMITTED UNDER THE REFERENCES: 9613350 - 2015 - 01091 -2, 9613350-2015-01501-001, 9613350-2015-01501-002) ALL ADDITIONAL INFORMATION AND DOCUMENTATION RECEIVED ON JULY 16, 2019 WERE ALREADY AVAILABLE IN (B)(4). BOTH COMPLAINTS REPORT THE SAME ISSUE. FOR THIS REASON, THE EVENT WILL BE COVERED IN ORIGINAL COMPLAINT (B)(4) AND (B)(4) WILL BE SET TO "NOT A COMPLAINT". PLEASE VOID IT FROM YOUR DATABASE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS BUT RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). ITEM REFERENCES UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462431 MODULAR HIP PROSTHESIS REVISION STEM N/A KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R