BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NTINUUM TM SHELL CLUST 56 KK

    MDR report key: 14135294 · Received April 18, 2022

    Report

    Report Number
    0001822565-2022-01023
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    March 21, 2022
    Report Date
    May 26, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024151437
    PMA / PMN Number
    K151448
    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

    (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: 0001822565-2022-01024, 0001822565-2022-01025. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 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
    2620291 NTINUUM TM SHELL CLUST 56 KK PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 77010387 00889024151437

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R