BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS SPOTORNO, STEM, 145°, UNCEMENTED, 6.0, TAPER 12/14

    MDR report key: 22814452 · Received August 15, 2025

    Report

    Report Number
    0009613350-2025-00651
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 22, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    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, G3, G6, H2, H3, H6, H11. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED THE RADIOLUCENT ACETABULAR CUP IS CEMENTED. THERE APPEARS TO BE SOME CHRONIC BONE LOSS AT THE SUPEROLATERAL ACETABULAR ROOF WITH THICK CEMENT PLACED IN THIS REGION. THE FEMORAL HEAD COMPONENT IS NOT CENTERED IN THE ACETABULAR CUP DUE TO SUPERIOR POLYETHYLENE WEAR. LEFT TOTAL HIP ARTHROPLASTY ASSOCIATED WITH SPIRAL FRACTURE OF THE PROXIMAL LEFT FEMUR. POTENTIAL RISK FACTORS INCLUDE GENERALIZED BONE MINERAL DENSITY. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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). D10. SULOX HEAD, S, ø 28/-3.5, TAPER 12/1 ITEM# 172805 LOT# 2072655. CMT CMW T.1 AVEC ANTIBIOTIQ ITEM# 3015040 LOT# B129A40. CMT CMW T.1 AVEC ANTIBIOTIQ ITEM# 3015040 LOT# C097A40. ALL POLY HOODED ACETABULAR CUP 46MM OD 28MM ID ITEM# 437028046 LOT# 1424182. G2. REPORT SOURCE: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A INITIAL HIP REPLACEMENT. SUBSEQUENTLY, APPROXIMATELY 24 YEARS POST IMPLANTATION, UNDERWENT A REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2687827 CLS SPOTORNO, STEM, 145°, UNCEMENTED, 6.0, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH B225980

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention| H SEE H11 NARRATIVE.