BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM LINER 28 X 38MM

    MDR report key: 10585675 · Received September 25, 2020

    Report

    Report Number
    0001822565-2020-03301
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    September 1, 2020
    Report Date
    November 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190656
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING DEFICIENCY WITH IE-14428 / CA-05854 INITIATED FOR FURTHER INVESTIGATION AND ROOT CAUSE DETERMINATION. IE-14428 AND CA-05854 WERE ISSUED BECAUSE THE LABELING SHOWED A LINER SIZE OF 38MM HOWEVER THE DEVICE PACKAGED WAS A SIZE 42MM. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 12-115111 ITEM NAME: BIOLOX HEAD, LOT NUMBER: 2971501. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2 MONTHS POST-IMPLANTATION DUE TO A RECALLED PRODUCT BEING IMPLANTED. THERE WAS NO REPORTED ISSUES WITH THE PRODUCT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053674 VIVACIT-E DM LINER 28 X 38MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64755636

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.