BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/260

    MDR report key: 8582005 · Received May 6, 2019

    Report

    Report Number
    0009613350-2019-00282
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    April 9, 2019
    Report Date
    July 24, 2020
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. NEW INFORMATION RECEIVED: IMPLANTATION DATE: 2005, EXACT DATE HAS BEEN REQUESTED. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    NOTE: THIS REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. ADDITIONAL INFORMATION AND INVESTIGATION SHOWED, THAT THE COMPLAINED PRODUCT IS (PROXIMAL PART OF REVITAN). THEREFORE PLEASE DELETE THIS REPORT FROM YOUR SYSTEM. PLEASE DELETE THIS REPORT: 0009613350-2019-00282-1 FROM YOUR SYSTEM. THIS INCIDENT IS FROM NOW ON COVERED IN REPORT: 0009613350-2020-00336.

    Description of Event or Problem · 0

    THE DEVICE WAS IMPLANTED IN 2005, EXACT DATE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    NOTE: THIS REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. ADDITIONAL INFORMATION AND INVESTIGATION SHOWED, THAT THE COMPLAINED PRODUCT IS (PROXIMAL PART OF REVITAN). THEREFORE PLEASE DELETE THIS REPORT FROM YOUR SYSTEM. PLEASE DELETE THIS REPORT: 0009613350-2019-00282-1 FROM YOUR SYSTEM. THIS INCIDENT IS FROM NOW ON COVERED IN REPORT: 0009613350-2020-00336.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 01.00405.318, LOT# UNKNOWN, REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/260. ITEM# 01.00402.075, LOT# 2211005, REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 75, TAPER 12/14. PMA/510K: 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 (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K071723. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE INVESTIGATION OF THE EVENT IS IN PROGRESS. X-RAYS, PHOTOS OF EXPLANTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION OR INVESTIGATION RESULT BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO PAIN AND RADIOGRAPHIC INDICATION OF IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374859 REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/260 NA KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R