BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR® MüLLER, STEM, LATERAL, UNCEMENTED, HA, 7, TAPER 12/14

    MDR report key: 21375106 · Received February 13, 2025

    Report

    Report Number
    0009613350-2025-00054
    Event Type
    Injury
    Date Received
    February 13, 2025
    Report Date
    May 15, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024479548
    PMA / PMN Number
    K200112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D6A. PRODUCT WAS IMPLANTED ON UNKNOWN DAY IN (B)(6) 2018. D10. BIOLOX® OPTION, HEAD, L, ø 36/+4.0, TAPER 8/10 ITEM# 00877503603 LOT# 2930007. G7 NEUTRAL ARCOMXL LNR 36MM F ITEM# 010000741 LOT# 6238073. 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. 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. THE TOXICOLOGICAL RISK ASSESSMENT OF THE AVENIR MÜLLER STEMS AND BIOLOX® DELTA HEAD HAS CONFIRMED THE BIOLOGICAL SAFETY OF THESE IMPLANT DEVICES FOR THE PATIENT. THE INSTRUCTIONS FOR USE (IFUS) OF THE INVOLVED PRODUCTS LIST AMONG THE CONTRAINDICATIONS: "ALLERGY TO THE IMPLANTED MATERIAL, ABOVE ALL TO METAL (EG. COBALT, CHROMIUM, NICKEL, ETC)." REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. NO MEDICAL RECORDS WERE REVIEWED, BUT INFORMATION THROUGH CORRESPONDENCE WITH THE PATIENT WERE RECEIVED. THE PATIENT EXPERIENCED BURNING AND TINGLING SENSATIONS IN THE MOUTH AND EXTREMITIES, WHICH WORSEN AFTER EXERCISE. THESE SYMPTOMS INITIALLY APPEARED AFTER THE CLOSURE OF AN ATRIAL SEPTAL DEFECT (ASD), DURING WHICH AN AMPLATZER DEVICE (WHICH CONTAINS NICKEL) WAS IMPLANTED AND LATER REMOVED DUE TO AN ALLERGIC REACTION. PATIENT HAD STERNAL TITANIUM PLATES IN PLACE AND PREVIOUSLY UNDERWENT HIP REPLACEMENT WITH TITANIUM IMPLANTS, WHICH DID NOT CAUSE ISSUES. PREVIOUSLY, THE PATIENT STATED THAT SHE SUSPECTED HER SYMPTOMS MAY BE DUE TO METAL HYPERSENSITIVITY, PARTICULARLY TO NICKEL OR OTHER METALS POTENTIALLY PRESENT IN THE STERNAL IMPLANT ALLOY. SHE ALSO CONSIDERED OXYGEN TOXICITY, SINCE SHE WAS PRESCRIBED SUPPLEMENTAL OXYGEN POST-ASD CLOSURE WITHOUT RE-EVALUATION, AND SOME SYMPTOMS DECREASED UPON DISCONTINUATION. HOWEVER, THE RECURRENCE OF SYMPTOMS AFTER A WORKOUT HAS RENEWED HER CONCERN. FOLLOW-UPS WERE PERFORMED TO CONFIRM ABOUT POSSIBLE PATIENT ALLERGY, BUT NO INFORMATION WAS PROVIDED. IT IS NOT POSSIBLE TO DETERMINE IF OR TO WHAT EXTEND OUR HIP IMPLANT CONTRIBUTED TO THE PATIENT¿S SYMPTOMS DUE TO THE PRESENCE OF MULTIPLE POTENTIAL SOURCES OF METAL EXPOSURE INCLUDING BOTH THE STERNAL IMPLANT AND THE LEFT-SIDED STRYKER HIP IMPLANT¿EACH CONTAINING DIFFERENT ALLOYS THAT COULD CONTRIBUTE TO HYPERSENSITIVITY OR SYSTEMIC REACTIONS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED, AND 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 APPROXIMATELY 6 YEARS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT ALLEGES PAIN IN HIP AND SEVERE ANAPHYLAXIS. IT IS UNKNOWN IF REVISION SURGERY IS PLANNED. 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
    100043 AVENIR® MüLLER, STEM, LATERAL, UNCEMENTED, HA, 7, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH 2899287 00889024479548

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11 NARRATIVE.