BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM 10 DEG LINER SZ 28

    MDR report key: 10835280 · Received November 13, 2020

    Report

    Report Number
    0001825034-2020-04082
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    July 2, 2020
    Report Date
    February 17, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS PROVIDED; ONE X-RAY WAS REVIEWED. THE X-RAY IS NOT RELEVANT FOR THIS COMPLAINT, DUE TO IT BEING TAKEN AT A LATER DATE. THE SALES REP HAS CONFIRMED ANY REVISION CORRELATING WITH THE X-RAY RECEIVED HAS BEEN CANCELLED. ADDITIONAL INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF PREVIOUS INVESTIGATION. 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 ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM # 16-104170 RNGLC+ LTD HOLE FIN SHELL SZ70 LOT# 124780R; ITEM # 11-107020 FREEDOM CONSTR HD 36MM T1 +6MM LOT# 879950; ITEM # 11-301312 ARCOS CON SZ B HI 60MM LOT# 935070; ITEM # 11-300818 ARCOS 18X150MM SPL TPR DIST LOT# 576520. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REVIEW OF THE STERILIZATION CERTIFICATE CONFIRMS THAT THE LOT WAS STERILIZED ACCORDING TO SPECIFICATIONS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03867. 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 UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED APPROXIMATELY 6 MONTHS LATER DUE TO UNKNOWN REASONS; THE HEAD AND LINER WERE REMOVED AND REPLACED. APPROXIMATELY 4 MONTHS AFTER THAT, PATIENT WAS REVISED AGAIN DUE TO MIGRATION AND INFECTION. THE CUP WAS REMOVED AND A HIP SPACER WAS PUT IN. IT WAS NOTED THAT A REVISION IS SCHEDULED. NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302841 FREEDOM 10 DEG LINER SZ 28 PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 125720

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| R SEE H10 NARRATIVE