BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CUP

    MDR report key: 22465282 · Received July 9, 2025

    Report

    Report Number
    0001822565-2025-02445
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    June 22, 2024
    Report Date
    July 31, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: CANADA. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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. BECKERS G, MORCOS MW, LAVIGNE M, MASSÉ V, KISS MO, VENDITTOLI PA. EXCELLENT RESULTS OF LARGE-DIAMETER CERAMIC-ON-CERAMIC BEARINGS IN TOTAL HIP ARTHROPLASTY AT MINIMUM TEN-YEAR FOLLOW-UP. J ARTHROPLASTY. 2024 DEC;39(12):3028-3035. DOI: 10.1016/J.ARTH.2024.06.045. EPUB 2024 JUN 22. PMID: 38909852.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. X-RAY IMAGES ARE PROVIDED WITHIN THE JOURNAL ARTICLE; HOWEVER IT IS UNKNOWN IF THEY ARE RELATED TO THIS PATIENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UNABLE TO CONFIRM COMPLAINT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE JOURNAL ARTICLE THAT THE PURPOSE OF THE STUDY WAS TO REPORT THE LONG-TERM REVISION AND REOPERATION RATES, CLINICAL RESULTS, NOISE OCCURRENCE AND INTENSITY, RADIOGRAPHICAL EVALUATION, AND SYSTEMIC TI ION LEVELS OF THE ORIGINAL COHORT WITH A MINIMUM OF 10 YEARS OF FOLLOW-UP. THE STUDY REVIEWED 246 PATIENTS WHO HAD 276 HIP ARTHROPLASTIES. IMPLANTS CONSISTED OF 215 CLS SPOTORNO (78%) (ZIMMER BIOMET); 53 PROFEMUR PRESERVE STEMS (19%) (MICROPORT ORTHOPEDICS INC); 7 WAGNER CONES (3%) (ZIMMER BIOMET); AND ONE MS-30 CEMENTED STEM (0.4%) (ZIMMER BIOMET). THE ACETABULAR COMPONENTS WERE MAXERA (ZIMMER BIOMET) WITH A MONOBLOCK BIOLOX DELTA CERAMIC LINER. THE STUDY POPULATION HAD A MEAN AGE OF 64 YEARS AT TIME OF SURGERY (RANGE, 27 - 83); (167 FEMALES, 109 MALES). THE CURRENT ARTICLE PROVIDES FOLLOW UP DATA AT 10.5 YEARS POSTOP (RANGE, 10 - 12 YEARS). THE STUDY REPORTED 1 PATIENT REQUIRED EARLY (LESS THAN 4 WEEKS) REVISION DUE TO INSUFFICIENT ACETABULAR PRIMARY FIXATION. THE PATIENT WAS REVISED TO A 2MM LARGER MAXERA CUP AT 6 WEEKS.

    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
    792931 UNK CUP PROSTHESIS, HIPS JDI ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H