BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNK STEM

    MDR report key: 22509181 · Received July 15, 2025

    Report

    Report Number
    0001822565-2025-02547
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    May 24, 2025
    Report Date
    April 28, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) G2: FOREIGN: CANADA. 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. BINIAM, B., BOURGET-MURRAY, J., BEAULÉ, P., KIM, P., GOFTON, W., & GRAMMATOPOULOS, G. (2025). DIFFERENCES IN PERIOPERATIVE OUTCOMES BETWEEN CONVERSION TOTAL HIP ARTHROPLASTY AFTER PREVIOUS PROXIMAL FEMUR FRACTURE AND PRIMARY TOTAL HIP ARTHROPLASTY. ARTHROPLASTY TODAY, 33, 101715.

    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 A JOURNAL ARTICLE THAT THE PURPOSE OF THE STUDY WAS TO COMPARE OUTCOMES BETWEEN CONVERSION TOTAL HIP ARTHROPLASTY (THA) AFTER PROXIMAL FEMUR FRACTURE (PFF) FIXATION AND PRIMARY THA FOR OSTEOARTHRITIS AND EXAMINES WHETHER FRACTURE TYPE AFFECTS RESULTS. THE SINGLE SITE, MULTI-SURGEON RETROSPECTIVE STUDY REVIEWED 87 CONSECUTIVE PATIENTS THAT UNDERWENT CONVERSION THA FOLLOWING SURGICAL FIXATION OF A PFF WITH A MINIMUM OF 2 YEAR FOLLOW UP. A SUBGROUP OF THIS WERE THA FOLLOWING INTRACAPSULAR (54 PATIENTS) AND EXTRACAPSULAR PFF (33 PATIENTS). INDICATION FOR CONVERSION THA INCLUDED THE FOLLOWING, AVASCULAR NECROSIS, HARDWARE FAILURE AND NONUNION OR FRACTURE. TO COMPARE OUTCOMES A GROUP OF PRIMARY THA WITH DIAGNOSIS OF OSTEOARTHRITIS THIS GROUP SERVED AS A THE STUDY CONTROL GROUP. THE IMPLANT OF CHOICE FOR ALL PRIMARY THA WAS G7 ACETABULAR SHELL AND WAS USED 57% OF THE TIME IN THE CONVERSION THA GROUP. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AT THE FINAL FOLLOW UP 23 OF THE 87 CONVERSION THA HAD EXPIRED, AND DATA WAS COLLECTED ON THE REMAINING 62 HIPS (64 PATIENTS). THE STUDY POPULATION HAD A MEAN AGE OF 65.6 -73.9 YEARS AT TIME OF SURGERY AND TOTAL OF 67 MALE AND 104 FEMALES. FOLLOW-UP WAS CONDUCTED AT MINIMUM OF 2 YEAR WITH A MEAN LENGTH OF FOLLOW-UP FOR 5.6 YEARS (2.3-13.1). COMPLAINT 1: THE STUDY REPORTED IN THE PRIMARY THA GROUP 11 COMPLICATIONS OCCURRED, 2 OF WHICH WERE PROXIMAL FEMUR FRACTURE (PFF) AND UNDERWENT REOPERATION.

    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
    473414 UNK STEM PROSTHESIS, HIPS LZO ZIMMER BIOMET, INC. N/A UNK

    Patients

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