BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC 12X140

    MDR report key: 16918317 · Received May 12, 2023

    Report

    Report Number
    0001825034-2023-01036
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    June 28, 2021
    Report Date
    July 13, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. COMPONENT CODE: MECHANICAL (G04) ¿ STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. COMPLAINT CONFIRMED BASED ON EVALUATION OF MEDICAL RECORDS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS/THESE ITEM(S) AND THE REPORTED PART AND LOT COMBINATION(S). MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: METALLOSIS FROM TRUNNION WEAR. HEAD REMOVED, NOTED METAL DEBRIS TO TRUNNION AND HEAD. CYSTIC CHANGES TO GREATER TROCHANTER. 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: 11-363665 36MM COCR MOD HD +9MM 943960. CP156354 MCLAUGHLIN ACET 54MM LNR SZ 24 884760. 103534 TI LOW PROFILE SCREW 6.5X35MM 619270. EP-105894 EPOLY RLC 36MM 10DEG SZ24 SZ24 231250. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 01030. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. FOUR YEARS POST IMPLANTATION THE PATIENT WAS REVISED DUE TO DISLOCATION. IT WAS NOTED DURING THE REVISION THE PATIENT HAD INSTABILITY POSTERIORLY, TISSUE DAMAGE TO THE POSTERIOR CAPSULE, AND BONE LOSS. THE STEM REMAINED IMPLANTED. A SECOND REVISION TOOK PLACE NINE YEARS LATER DUE TO METALLOSIS FROM TRUNNION WEAR. DURING THE REVISION NOTED LARGE AMOUNT OF CLOUDY YELLOW FLUID, METAL DEBRIS, CYSTIC CHANGES TO GREATER TROCHANTER, AND NO VASCULARITY TO ACETABULUM AND FEMUR. ALL COMPONENTS WERE EXCHANGED WITH COMPETITOR PRODUCT AND A COMPETITOR CERCLAGE WIRE TO THE GREATER TROCHANTER AS A PREVENTIVE MEASURE DUE TO THIN BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604311 BI-METRIC/X POR NC 12X140 PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 336810

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H