BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 55, TAPER 12/14

    MDR report key: 17245312 · Received July 3, 2023

    Report

    Report Number
    0009613350-2023-00339
    Event Type
    Injury
    Date Received
    July 3, 2023
    Date of Event
    June 6, 2023
    Report Date
    August 25, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    UDI-DI
    00889024502956
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. D10 - METASUL HEAD 28MM M 12/14 ITEM#192806, LOT#2223704 REVITAN, DISTAL PART, CURVED, UNCEMENTED, 18/200 ITEM# 01.00406.218, LOT#2221255 UNKNOWN INLAY ITEM# UNKNOWN LOT# UNKNOWN IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED BECAUSE THE PROXIMAL PART WAS NOT CONTRIBUTING TO THE EVENT. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ UNKNOWN REVITAN DISTAL STEM ITEM# UNKNOWN LOT# UNKNOWN. G2 ¿ REPORT SOURCEFOREIGN ¿ GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED BECAUSE THE PROXIMAL PART WAS NOT CONTRIBUTING TO THE EVENT. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT HIP REVISION OF THE PROXIMAL PART DUE TO IMPLANT FRACTURE, APPROXIMATELY NINETEEN (19) YEARS FROM IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21598 REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 55, TAPER 12/14 HIP PROSTHESIS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2214304 00889024502956

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H