BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIT E NEUTRAL LNR 36MM E

    MDR report key: 14310354 · Received May 6, 2022

    Report

    Report Number
    0001822565-2022-01263
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    February 27, 2022
    Report Date
    June 7, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024519909
    PMA / PMN Number
    K190660
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000663, G7 PPS LTD ACET SHELL 52E, 7085907. 00625006530, BONE SCR 6.5X30 SELF-TAP, J7146596. 650-0661, DELTA CERAMIC FEM HD 36/0MM, 3035189. 192108, ECHO POR FMRL LAT NC 8X120MM, 377850. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, 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 COMPLAINT CONFIRMED VIA MEDICAL RECORDS AND RADIOGRAPHS REVIEWED BY A HEALTH CARE PROFESSIONAL. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO THE PATIENT FAILING TO FOLLOW MEDICAL ADVICE AND BENDING FORWARD WITH EXTERNAL ROTATION THAT CAUSED THE HIP TO DISLOCATE. IT WAS NOTED THE PHYSICIAN HAD TO REMIND THE PATIENT AGAIN ABOUT HIP POSITIONING PRECAUTIONS. 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 PATIENT UNDERWENT A RIGHT HIP CLOSED REDUCTION APPROXIMATELY 21 DAYS POST IMPLANTATION DUE TO DISLOCATION. THE PATIENT WAS SITTING IN A RECLINER, REACHED FORWARD TO PULL UP RIGHT SOCK CAUSING EXTERNAL ROTATION AND DISLOCATED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099601 G7 VIT E NEUTRAL LNR 36MM E PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65207737 00889024519909

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other