BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INLAY FOR A STRATEC CUP, SIZE 50/28 DYSPLASIA.

    MDR report key: 7235829 · Received February 2, 2018

    Report

    Report Number
    0001825034-2018-00608
    Event Type
    Injury
    Date Received
    February 2, 2018
    Report Date
    June 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REPLACEMENT INLAY FOR A STRATEC CUP SIZE 50/28 DYSPLASIA. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE COMPATIBILITY CHECK AND COMPLAINT HISTORY SEARCH WERE NOT PERFORMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 · 1

    IT WAS REPORTED THAT THE PATIENT HAD REPLACEMENT INLAY FOR A STRATEC CUP SIZE 50/28 DYSPLASIA, BY DR. (B)(6). THIS IS A NORMAL REVISION SURGERY AFTER THE INLAY WAS IMPLANTED IN 2002 (15 YEARS OF USAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78969 INLAY FOR A STRATEC CUP, SIZE 50/28 DYSPLASIA. HIP - IMPLANT JDI ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R