BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIT E NEUTRAL LNR 36MM F

    MDR report key: 15787988 · Received November 14, 2022

    Report

    Report Number
    0001822565-2022-03200
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    August 1, 2022
    Report Date
    November 23, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 51-104160 ¿ TAPERLOC STEM ¿ 7011414, 010000665 ¿ G7 SHELL ¿ 7001751, 650-0661 ¿ DELTA CERAMIC HEAD - 3062058. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6 MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT THA WAS PERFORMED. SUBSEQUENTLY THE PATIENT EXPERIENCED A DISLOCATION CORRECTED WITH A CLOSED REDUCTION ON FROM BENDING TO PICK UP A BOX. THE PATIENT WAS REVISED ON DUE TO CONTINUED DISLOCATIONS AND INSTABILITY. DURING THE REVISION, TEARING OF THE POSTERIOR CAPSULE WAS FOUND, AS WELL AS SCAR TISSUE AND HETEROTOPIC OSSIFICATION IN THE FEMUR AND ANTERIOR CAPSULE. THE HEAD AND LINER WERE EXPLANTED, AND UNKNOWN PRODUCTS WERE PLACED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS NOTED THE PATIENT HAS DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSIS WHICH PUTS MORE STRESS ON THE HIP WHEN BENDING. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 1 YEAR POST IMPLANTATION DUE TO DISLOCATION AND INSTABILITY. DURING THE PROCEDURE, EXTENSIVE SCAR TISSUE WAS NOTED THROUGHOUT THE JOINT, TISSUE DAMAGED TO THE POSTERIOR CAPSULE AND HETEROTOPIC BONE TO FEMUR AND ACETABULUM. THE HEAD AND LINER WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364777 G7 VIT E NEUTRAL LNR 36MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65165414

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H