BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENT PRI LIP BRG 12X71/75

    MDR report key: 12099738 · Received July 1, 2021

    Report

    Report Number
    0001825034-2021-01949
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 3, 2021
    Report Date
    July 1, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K982869
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS NOT RETURNED BY THE FACILITY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. WITH THE LIMITED INFORMATION AVAILABLE WE WERE UNABLE TO DETERMINE WHICH OF THE TWO LISTED DEVICES WERE EXPLANTED. BOTH ARE BEING REPORTED UNDER THIS MDR TO AVOID DUPLICATION. 179321 ASCENT PRI LIP BRG LOT# 685050; 179331 ASCENT PRI LIP BRG LOT# 624390. ADDITIONAL ASSOCIATED PRODUCTS AND MDRS: 179013 ASCENT PRI INLK FMRL MED LT LOT# 771170, MDR: 0001825034-2021-01946. 141224 BIOMET CC I-BEAM TRAY LOT# 712590; 141225 BIOMET CC I-BEAM TRAY LOT# 754160, MDR: 0001825034-2021-01947. 11-150842 BMET ARCOM AP PAT 3PST LOT# 800090; 11-150842 BMET ARCOM AP PAT 3PST LOT# 741540, MDR: 0001825034-2021-01948.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING. NO ADDITIONAL INFORMATION ACCORDING TO PER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000862 ASCENT PRI LIP BRG 12X71/75 PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 685050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R