BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STEM

    MDR report key: 24687454 · Received March 25, 2026

    Report

    Report Number
    0001822565-2026-00946
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    November 29, 2025
    Report Date
    December 9, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. D10: CAT # 010000703 LOT# 7840937 G7 BONEMASTER LTD ACET SHL 52E. G2: FOREIGN: AUSTRALIA. NO PRODUCT WAS RETURNED; FURTHER VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: 2 AP PELVIS/PROXIMAL FEMUR RADIOGRAPHS ARE REVIEWED, OBTAINED AT PRE-REVISION AND POST-REVISION TIME POINTS. THE PREREVISION RADIOGRAPH SHOWS PRESENCE OF LEFT HIP TOTAL ARTHROPLASTY. RADIOLUCENCY IS PRESENT AT THE FEMORAL STEM TIP METAL-BONE AND METAL-CEMENT INTERFACES WHICH MAY INDICATE LOOSENING. THE ACETABULAR CUP LATERAL ANGLE OF INCLINATION IS ABNORMALLY STEEP. LEG LENGTH DISCREPANCY IS PRESENT, WITH LEFT LEG RELATIVELY SHORT. HETEROTOPIC BONE PROJECTS JUST PROXIMAL TO THE LEFT HIP LESSER TROCHANTER AND FAINT SMALL HETEROTOPIC OSSIFICATION PROJECTS LATERAL TO THE LEFT HIP. POST-REVISION AP PELVIS/PROXIMAL FEMUR RADIOGRAPHS SHOWS PRESENCE OF LEFT TOTAL HIP ARTHROPLASTY. THE ACETABULAR CUP HAS BEEN REVISED. THE ACETABULAR CUP LATERAL ANGLE OF INCLINATION IS NOW STANDARD. FINDINGS ARE OTHERWISE SIMILAR TO THE EARLIER PRE-REVISION RADIOGRAPH. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE X-RAY REVIEW SUGGESTS THE CUP INCLINATION IS A RISK FACTOR FOR THE DISLOCATION. THE POSITIONING OF IMPLANTS ARE AT THE SURGEONS DISCRETION AND DEPENDS ON THE PATIENTS ANATOMY. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED 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 UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 6 WEEKS LATER DUE TO DISLOCATION. DURING THE REVISION, THE ORIENTATION OF THE CUP WAS CHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748527 UNK STEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Unknown Hospitalization| R SEE H11 NARRATIVE