BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E 32MM I.D. SIZE KK NEUTRAL LINER USE WITH 56MM O.D.

    MDR report key: 18696582 · Received February 13, 2024

    Report

    Report Number
    0001822565-2024-00419
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    January 5, 2024
    Report Date
    May 23, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQG
    PMA / PMN Number
    K120370
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: COUNTRY: JAPAN. D10: CAT#: 00885101232, LOT#: 63306634, 32MM I.D. SIZE KK NEUTRAL LINER. CAT#: 00625006520, LOT#: 63506572, BONE SCR 6.5X20 SELF-TAP. CAT#: 00625006520, LOT#: 63480615, BONE SCR 6.5X20 SELF-TAP. CAT#: 51-145040, LOT#: 2931541, TPRLC XR MP TYPE1 PPS 4.0. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2024-00418.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. NO PRODUCT WAS RETURNED; HOWEVER, PICTURES WERE PROVIDED. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED WEAR TO THE INNER AND OUTER SPHERICAL SURFACES OF BOTH DEVICES. THEY WERE ALSO COVERED IN BIO-DEBRIS. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURES. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. THE REPORTED ISSUE CANNOT BE CONFIRMED. MEDICAL RECORDS WERE NOT PROVIDED TO CONFIRM THE OSTEOLYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 7 YEARS POST IMPLANTATION OF A LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PAIN AND OSTEOLYSIS. THE CUP AND HEAD WERE REPLACED. THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798887 VIVACIT-E 32MM I.D. SIZE KK NEUTRAL LINER USE WITH 56MM O.D. PROTHESIS, HIP OQG ZIMMER BIOMET, INC. N/A 63306634

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H