BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRAL 180 ORIMARY/REVISION

    MDR report key: 22839783 · Received August 19, 2025

    Report

    Report Number
    0001825034-2025-02531
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    June 17, 2016
    Report Date
    August 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10 , G3, G6, H2, H3, H6, H10, H11. THE FOLLOWING SECTION WAS CORRECTED: D4 (EXPIRATION DATE) D10: #ITEM: US157856 #NAME: M2A-MAGNUM PF CUP 56ODX50ID #LOT: 790610 #ITEM: 157450 #NAME: M2A-MAGNUM MOD HD SZ 50MM #LOT: 833600 #ITEM: 139259 #NAME: M2A MAGNUM 42-50M TPR INSRT +6 #LOT: 230980 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. RECORDS NOTED THAT ON (B)(6) 2016 1ST STAGE REVISION. INFECTED RIGHT TOTAL HIP REPLACEMENT. ACETABULUM EXPLANTED WITH SOME METAL REACTION ANTERIORLY THAT WAS EXCISED. CEMENT SPACER INSERTED. (B)(6) 2016 2ND STAGE REVISION. CEMENT SPACER EXPLANTED. PERMANENT COMPONENTS IMPLANTED WITHOUT COMPLICATIONS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED BASED ON THE MEDICAL RECORD FINDINGS. 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). G2: FOREIGN ¿ CANADA . H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) ¿ STEM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY SIX YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A TWO STAGE RIGHT HIP REVISION DUE TO INFECTION. DURING THE FIRST REVISION, METAL REACTION WAS NOTED ANTERIORLY. ALL COMPONENTS WERE REVISED AND A CEMENT SPACER USED. SECOND STAGE REVISION WAS COMPLETED TO IMPLANT DEFINITIVE IMPLANTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252109 INTEGRAL 180 ORIMARY/REVISION PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 018590

    Patients

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