BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS STEM 135DEG 8.0 12/14

    MDR report key: 22289550 · Received June 19, 2025

    Report

    Report Number
    0009613350-2025-00449
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    May 26, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): D10: ITEM # 172805, SULOX¿¢, HEAD, S, ø 28/-3.5, TAPER 12/14, LOT # 2606718, ITEM # 6320-50-28, LINER 20DEG, LOT # 62195684. G2: REPORT SOURCE NEW ZEALAND. 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 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. CORRECTED: B1 - PRODUCT HAS NOT BEEN EVALUATED AS IT HAS BEEN DETERMINED THE EVENT IS NOT RELATED TO DEVICE. - DEVICES ARE USED FOR TREATMENT. - REPORTED EVENT IS NOT RELATED TO DEVICE THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. - NO FURTHER ACTIONS WILL BE INITIATED AS A RESULT OF REPORTED EVENT. - ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. IT WAS REPORTED A PATIENT WAS IN A BIKE ACCIDENT LEADING TO A FRACTURE OF THE FEMORAL BONE. TRAUMATIC EVENTS, SUCH AS A BIKE ACCIDENT CAN LEAD TO IMPLANT LOOSENING, BONE AND/OR IMPLANT FRACTURE(S), DISLOCATION, DISASSOCIATION AND/OR MIGRATION OF THE PROSTHESIS. AS THE COMPLAINT INDICATES, THE PATIENT SUSTAINED AN EXTERNAL TRAUMA THAT CAUSED THE COMPLICATION WITH NO ALLEGATIONS AGAINST THE DEVICE PRIOR TO THE EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED A RIGHT TOTAL HIP ARTHROPLASTY. HARDWARE APPEARS INTACT. THE ACETABULAR CUP IS IN STANDARD POSITION AND SHOWS NO EVIDENCE OF LOOSENING. THE FEMORAL STEM IS IN VARUS ALIGNMENT. RADIOLUCENT LINES AT THE FEMORAL STEM BONE-METAL INTERFACE APPEAR TO BE ARTIFACTUAL. A SHARD OF CORTICAL BONE PROJECTS MEDIAL TO THE FEMORAL NECK CONSISTENT WITH A FRACTURE FRAGMENT. GENERALIZED REDUCED BONE MINERAL DENSITY IS NOTED. 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 PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO FRACTURE OF FEMORAL BONE AFTER BIKE ACCIDENT. TRILOGY CUP AND SCREWS RETAINED, CLS STEM REMOVED (GOOD BONE INGROWTH) AND HEAD REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724210 CLS STEM 135DEG 8.0 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH 2452359

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Hospitalization| R SEE H11 NARRATIVE.