BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENT PRI INLK FMRL MED LT

    MDR report key: 12099633 · Received July 1, 2021

    Report

    Report Number
    0001825034-2021-01946
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 3, 2021
    Report Date
    November 10, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICES OR PHOTOGRAPHS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NO COMPATIBILITY ISSUES WERE NOTED. MEDICAL RECORDS WERE NOT PROVIDED. THIS COMPLAINT CANNOT BE CONFIRMED. ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    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 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. ADDITIONAL ASSOCIATED PRODUCTS AND MDRS. 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. 179321 ASCENT PRI LIP BRG LOT# 685050. 179331 ASCENT PRI LIP BRG LOT# 624390. MDR: 0001825034-2021-01949.

    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
    997418 ASCENT PRI INLK FMRL MED LT PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 771170

    Patients

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