BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)

    MDR report key: 12982312 · Received December 13, 2021

    Report

    Report Number
    0008031020-2021-00495
    Event Type
    Injury
    Date Received
    December 13, 2021
    Date of Event
    November 16, 2021
    Report Date
    March 30, 2022
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    NTG
    UDI-DI
    00886385026923
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE CORRECTIONS IN D3 MANUFACTURER ENTITY, THE FDA REGISTRATION NUMBER FOR ENCORE MEDICAL, L.P. IS (B)(4) THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT SUCH AS THE INFECTION FORM FILLED BY THE CUSTOMER MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "INFECTION AFTER PRIOR REVISION SURGERY. POLY REMOVED. STAGED INFECTION CONTROL. REINSERTED NEW POLY TODAY."

    Description of Event or Problem · 0

    AS REPORTED: "INFECTION AFTER PRIOR REVISION SURGERY. POLY REMOVED. STAGED INFECTION CONTROL. REINSERTED NEW POLY TODAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888117 SLIDING CORE, UHMPWE,6M (STERILE PACKAGED) PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED NTG ENCORE MEDICAL, L.P. 400-140F 1948287 00886385026923

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R