BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNK STEM

    MDR report key: 23879814 · Received December 23, 2025

    Report

    Report Number
    0001822565-2025-04769
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    June 27, 2025
    Report Date
    May 5, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. CORRECTED: E3. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). A2 AND 3: ONE 84YO MALE AND ONE 80YO FEMALE. G2: FOREIGN: SPAIN. SUGGESTED COMPONENT CODE- MECHANICAL (G04): STEM. 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. REFERENCE: CRUZ-PARDOS, A., & GARCÍA-REY, E. (2025). IMPACTION BONE GRAFTING COMBINED WITH LATERAL TRABECULAR AUGMENTS IN ACETABULAR REVISION SURGERY: A CASE-CONTROL STUDY. HIP INTERNATIONAL: THE JOURNAL OF CLINICAL AND EXPERIMENTAL RESEARCH ON HIP PATHOLOGY AND THERAPY, 35(5), 502¿509. HTTPS://DOI.ORG/10.1177/11207000251351270.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS OBTAINED THAT REPORTED A RETROSPECTIVE STUDY FROM SPAIN. THE PURPOSE OF THE STUDY WAS TO HYPOTHESIZED THAT IBG (IMPACTION BONE GRAFTING) COMBINED WITH LATERAL TRABECULAR AUGMENTS IN LARGE SEGMENTAL ACETABULAR BONE DEFECTS CAN PROVIDE COMPARABLE RESULTS TO IBG COMBINED WITH CONVENTIONAL METALLIC MESHES. THE STUDY REVIEWED A TOTAL OF 382 ACETABULAR REVISIONS WERE PERFORMED IN OUR INSTITUTION USING IBG WITH A CEMENTED CUP (COMPETITOR PRODUCT). WE IDENTIFIED 30 HIPS IN 30 PATIENTS IN WHOM THIS TECHNIQUE WAS COMBINED WITH A LATERAL TM AUGMENT (CASE GROUP). A POSTEROLATERAL APPROACH WAS USED BY THE SAME SURGICAL TEAM. THE STUDY POPULATION HAD A MEAN AGE OF 65.8 YEARS AT TIME OF SURGERY; 53.3% MALES/46.7% FEMALES. ALL PATIENTS HAD A FOLLOW-UP OCCURRED AT 6 WEEKS, 3MONTHS, 6MONTHS, 1 YEAR, AND ANNUALLY THEREAFTER, WITH A RANGE 4¿14 YEARS. COMPLAINT 1: THE LITERATURE REPORTED THAT TWO PATIENTS IN THE CASE GROUP REQUIRED RE-REVISION SURGERY DUE TO ASEPTIC LOOSENING. THE FIRST PATIENT, AN 84-YEAR-OLD MALE, UNDERWENT REVISION ONE MONTH POSTOPERATIVELY, DURING WHICH A NEW TRABECULAR METAL (TM) AUGMENT AND SUPEROLATERAL MESH WERE IMPLANTED. THE SECOND PATIENT, AN 80-YEAR-OLD FEMALE, UNDERWENT REVISION 46 MONTHS POSTOPERATIVELY; IN THIS CASE, THE TM AUGMENT WAS REMOVED AND A SUPEROLATERAL MESH WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466078 UNK STEM PROSTHESIS, HIPS LZO ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1