BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIT E LINER ELEVATED KK 36

    MDR report key: 14117314 · Received April 15, 2022

    Report

    Report Number
    0001822565-2022-01024
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    March 21, 2022
    Report Date
    May 20, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQG
    UDI-DI
    00889024155589
    PMA / PMN Number
    K120370
    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

    (B)(4). CATALOG NUMBER:00-8757-056-01, LOT NUMBER:77010387 BRAND NAME: CONTINUUM TM SHELL. CATALOG NUMBER:00-8852-012-36, LOT NUMBER: 64802356 BRAND NAME: VIT E LINER ELEVATED. CATALOG NUMBER:00-7848-022-00, LOT NUMBER:64746102 BRAND NAME: KINECTIV MODULAR. CATALOG NUMBER:00-6250-065-30, LOT NUMBER:J6793110 BRAND NAME: BONE SCREW. CATALOG NUMBER:00-6250-065-36, LOT NUMBER:J6828155 BRAND NAME: BONE SCREW. CATALOG NUMBER: 00-7713-011-00, LOT NUMBER:64816986 BRAND NAME: M/L TAPER STEM. CATALOG NUMBER: 00-8775-036-02, LOT NUMBER:3043607 BRAND NAME: BIOLOX DELTA HEAD. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT: 0001822565-2022-01023 AND 0001822565-2022-01025. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THEINVESTIGATION 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. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SLIGHT DECREASED LATERAL INCLINATION OF THE LEFT ACETABULAR CUP. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. ROOT CAUSE COULD NOT BE DETERMINED. 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 THE PATIENT WAS REVISED DUE TO PAIN AND POOR CUP POSITION APPROXIMATELY 2 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136966 VIT E LINER ELEVATED KK 36 PROSTHESIS, HIP OQG ZIMMER BIOMET, INC. N/A 64802356 00889024155589

    Patients

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