BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC HD ARCOM XL 28X38MM

    MDR report key: 8653838 · Received May 30, 2019

    Report

    Report Number
    0001825034-2019-02353
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    January 11, 2019
    Report Date
    November 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: CONTRIBUTING FACTORS OF EVENT: PATIENT HISTORY OF RECREATIONAL DRUG ABUSE AND ALCOHOL INTAKE. MILD MYOCARDIAL INFARCTION, NAUSEA AND VOMITING, PER PATIENT REPORT, RECORDS ARE LIMITED. 3 NIGHTS HOSPITALIZATION, FLUIDS AND ELECTROLYTES, ELECTIVE CARDIAC CATHETERIZATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 00625006535 LOT NUMBER:64190171 BRAND NAME: BONE SCREW, CATALOG NUMBER:00625006525 LOT NUMBER:64124990 BRAND NAME: BONE SCREW, CATALOG NUMBER: 00877502802 LOT NUMBER: 2960402 BRAND NAME: BIOLOX DELTA CERAMIC HEAD, CATALOG NUMBER: 00771100910 LOT NUMBER:63994695 BRAND NAME: M/L TAPER STEM, CATALOG NUMBER:110024461 LOT NUMBER:599730 BRAND NAME: G7 DUAL MOBILITY, CATALOG NUMBER:010000661 LOT NUMBER: 3442540 BRAND NAME: ACT ARTIC HD ARCOM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02352, 0001825034-2019-02351. 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. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT HOSPITALIZATION AND A CARDIAC CATHETERIZATION DUE TO MYOCARDIAL INFARCTION APPROXIMATELY 44 DAYS POST IMPLANTATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449266 ACT ARTIC HD ARCOM XL 28X38MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 332220

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization