BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 6, TAPER 12/14

    MDR report key: 21548640 · Received March 7, 2025

    Report

    Report Number
    0009613350-2025-00092
    Event Type
    Injury
    Date Received
    March 7, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024591011
    PMA / PMN Number
    K193030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +3.5 MM NECK LENGTH ITEM# 802202803 LOT# 3172961. G2. REPORT SOURCE: FRANCE. 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.

    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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT HAS BEEN DEALING WITH PAIN, DISCOMFORT, AMBULATION DIFFICULTIES, INSTABILITY, LEG LENGTH DISCREPANCY, DIFFICULTY WITH GETTING IN AND OUT OF VEHICLE, AND FEAR OF METAL TOXICITY. A RADIOGRAPHIC IMAGE WAS PROVIDED AND REVIEWED BY A RADIOLOGIST. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: MALPOSITION OF THE ACETABULAR CUP AND POSSIBLE POLYETHYLENE WEAR. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED THE PROVIDED DOCUMENTATION CONFIRMS THE IMPLANTATION OF COMPETITOR ACETABULAR COMPONENTS IN COMBINATION WITH ZIMMER BIOMET ACETABULAR COMPONENTS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THIS REPRESENTS OFF-LABEL USE. IF AND TO WHAT EXTENT THE OFF-LABEL USE, ACETABULAR CUP MALPOSITION, AND POSSIBLE POLYETHYLENE WEAR ARE RELATED TO EACH OTHER, AND IF AND TO WHAT EXTENT THEY OR OTHER PATIENT AND/OR PROCEDURE RELATED FACTORS, CONTRIBUTED TO THE REPORTED EVENT, REMAIN UNKNOWN. IN ADDITION, A REVIEW OF THE MANUFACTURING PROCESS DOCUMENTATION CONFIRMS THAT POTENTIAL MANUFACTURING-RELATED ISSUES CAN BE EXCLUDED. AS SUCH, BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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 HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. THE PATIENT HAS HAD PAIN, DISCOMFORT, AMBULATION DIFFICULTIES, INSTABILITY, LEG LENGTH DISCREPANCY, DIFFICULTY WITH GETTING IN AND OUT OF VEHICLE, AND FEAR OF METAL TOXICITY SINCE INITIAL SURGERY. NO TREATMENT HAS BEEN REPORTED, AND ALL COMPONENTS REMAIN IMPLANTED. PATIENT WILL FOLLOW-UP WITH A NEW SURGEON APPROXIMATELY 9 MONTHS POST-IMPLANTATION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    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
    905937 AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 6, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH 3168060 00889024591011

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other