BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 75, TAPER 12/14

    MDR report key: 15985671 · Received December 15, 2022

    Report

    Report Number
    0009613350-2022-00650
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    October 18, 2022
    Report Date
    February 2, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    UDI-DI
    00889024503021
    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). REPORT SOURCE -FOREIGN - GERMANY. CONCOMITANT MEDICAL PRODUCTS: REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/200, ITEM#0100402075 , LOT# 2953434. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2022 - 00590. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. DISTAL AND PROXIMAL PART OF THE STEM WERE RECEIVED FOR EXAMINATION. THE STEM WAS RECEIVED DISASSOCIATED AT THE CONNECTION BETWEEN THE CONNECTION PIN AND THE PROXIMAL PART. THE DISTAL PART AND THE CONNECTION PIN ARE STILL ASSEMBLED. REVISION DAMAGE IN THE FORM OF DEEP SCRATCHES CAN BE SEEN ON THE DISTAL PART. NO SIGNS OF BONE ONGROWTH ON THE DISTAL PART. ON THE PROXIMAL PART IT IS POSSIBLE TO SEE LIGHT SCRATCHES MOST LIKELY COMING FROM REVISION SURGERY. ON THE NECK OF THE TAPER THERE IS A LARGE POLISHED AREA. NO SIGNS OF BONE ONGROWTH ON THE PROXIMAL PART. THE PRESS-FIT REGION OF THE PROXIMAL PART IS NO LONGER IN ITS ORIGINAL SHAPE: THE WALL ON THE MEDIAL-POSTERIOR SIDE IS EXTREMELY DEFORMED AND THINNED; THE INSIDE SURFACE ON THE PRESS-FIT REGION SHOWS HEAVY SIGNS OF WEARING TO THE POINT THAT MATERIAL WAS TAKEN AWAY. THIS DAMAGES ARE MOST LIKELY DUE TO MOVEMENT OF THE DISASSOCIATED PIN IN THE PRESS-FIT REGION. REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CHECK-UP AT (B)(6) HOSPITAL, IMPLANT FAILURE WITH CONE FRACTURE OF THE LEFT HIP WAS IDENTIFIED. REVISION SURGERY TOOK PLACE APPROXIMATELY ONE MONTH PRIOR TO THIS REPORT. DURING THE REVISION PROCEDURE METALLOSIS WAS OBSERVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258728 REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 75, TAPER 12/14 HIP PROSTHESIS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2953434 00889024503021

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| H