BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/200

    MDR report key: 15995183 · Received December 16, 2022

    Report

    Report Number
    0009613350-2022-00659
    Event Type
    Injury
    Date Received
    December 16, 2022
    Report Date
    February 14, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024592896
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 85, TAPER 12/14; ITEM# 01.00402.085; LOT# 2200045. UNKNOWN ACETABULAR CUP; ITEM# UNKNOWN; LOT# UNKNOWN. UNKNOWN FEMORAL HEAD; ITEM# UNKNOWN; LOT# UNKNOWN. REPORT SOURCE¿ FOREIGN: GERMANY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2022 - 00660, 0009613350 - 2022 - 00661, 0009613350 - 2022 - 00662. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED: PRODUCT EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. THE PATIENT IS MALE, AT THE TIME OF THE REPORTED EVENT HE IS 47 YEARS OLD. THE PATIENT UNDERWENT A FIRST BILATERAL THA BECAUSE OF DYSPLASTIC ARTHROSIS AT BOTH SIDES. 3 YEARS LATER A REVISION SURGERY WAS PERFORMED ON THE RIGHT HIP BECAUSE OF STEM LOOSENING: AS OP NOTES REPORT, DURING SURGERY THE STEM WAS REPLACED. HOWEVER, IT IS NOT CLEAR IF ALSO THE HEAD AND THE CUP WERE REPLACED. BASED ON THE PROVIDED MEDICAL RECORDS, THE CONCENTRATION LEVEL OF CO AND CR IONS IN THE BLOOD ARE ABOVE THE DOCUMENTED THRESHOLD. THE AVAILABLE DATA IS NOT SUFFICIENT TO DEEPLY INVESTIGATE ON THE PRODUCTS INVOLVED IN REPORTED EVENT. PROXIMAL AND DISTAL PART OF THE REVITAN STEM ARE KNOWN, BUT THEY WERE NOT RETURNED FOR INVESTIGATION. HEAD AND CUP ARE UNKNOWN. WITH THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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 THE PATIENT UNDERWENT A BILATERAL TOTAL HIP ARTHROPLASTY AND APPROXIMATELY 18 YEARS LATER, DURING MEDICAL CHECKUPS ELEVATED METAL IONS (COBALT AND CHROMIUM) WERE IDENTIFIED IN BLOOD WORK. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    1258366 REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/200 PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2199191 00889024592896

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other