BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 46MM G

    MDR report key: 13481297 · Received February 8, 2022

    Report

    Report Number
    0001825034-2022-00300
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    January 14, 2022
    Report Date
    May 26, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQG
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS DEVICE WAS DETERMINED TO BE NOT REPORTABLE AND NOT RELATED TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. THIS EVENT IS REPORTED UNDER 0001822565-2022-00379 AND 3002806535-2022-00053.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#11-301302, ARCOS CON SZ B STD 60MM, LOT#360360. CAT#11-300808, ARCOS 18X150MM SPL TPR DIST, LOT#221260. CAT#650-1064, CER OPTION TYPE 1 TPR SLEVE -6 , LOT#3032903. CAT#650-1055. CER BIOLOXD OPTION HD 28MM, LOT#3062495. CAT#110031013. VIVACIT-E DM BEARING 28X46MM, CAT#65016432. CAT#00625006535, BONE SCR 6.5X35 SELF-TAP, LOT#J6851898. CAT#00625006535, BONE SCR 6.5X35 SELF-TAP, LOT#J6851905. CAT#110010267, G7 OSSEOTI MULTIHOLE 58MM G, LOT#6512782. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY HOSPITAL; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#11-301302, ARCOS CON SZ B STD 60MM, LOT#360360. CAT#11-300808, ARCOS 18X150MM SPL TPR DIST, LOT#221260. CAT#650-1064, CER OPTION TYPE 1 TPR SLEVE -6 , LOT#3032903. CAT#650-1055. CER BIOLOXD OPTION HD 28MM, LOT#3062495. CAT#110031013. VIVACIT-E DM BEARING 28X46MM, CAT#65016432. CAT#00625006535, BONE SCR 6.5X35 SELF-TAP, LOT#J6851898. CAT#00625006535, BONE SCR 6.5X35 SELF-TAP, LOT#J6851905. CAT#110010267, G7 OSSEOTI MULTIHOLE 58MM G, LOT#6512782. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY HOSPITAL; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS DEVICE WAS DETERMINED TO BE NOT REPORTABLE AND NOT RELATED TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. THIS EVENT IS REPORTED UNDER 0001822565-2022-00379 AND 3002806535-2022-00053.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT BECAME DISLOCATED AND COULD NOT BE REDUCED THROUGH CLOSED REDUCTION. HAD TO OPEN AND FOUND FEMORAL HEAD BECAME DISASSOCIATED FROM DM POLY LINER. DM CONSTRUCT REMOVED AND FREEDOM CONSTRUCT PUT IN PLACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT BECAME DISLOCATED AND COULD NOT BE REDUCED THROUGH CLOSED REDUCTION. HAD TO OPEN AND FOUND FEMORAL HEAD BECAME DISASSOCIATED FROM DM POLY LINER. DM CONSTRUCT REMOVED AND FREEDOM CONSTRUCT PUT IN PLACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302912 G7 DUAL MOBILITY LINER 46MM G PROSTHESIS, HIP OQG ZIMMER BIOMET, INC. N/A 371300

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE