BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X35 SELF-TAP

    MDR report key: 8653823 · Received May 30, 2019

    Report

    Report Number
    0002648920-2019-00380
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    January 11, 2019
    Report Date
    October 22, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MRA
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE PATIENT UNDERWENT HOSPITALIZATION AND A CARDIAC CATHETERIZATION DUE TO MYOCARDIAL INFARCTION. MILD MYOCARDIAL INFARCTION, NAUSEA AND VOMITING, PER A 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: 00771100910 LOT NUMBER:63994695 BRAND NAME: M/L TAPER STEM, CATALOG NUMBER:00625006525 LOT NUMBER:64124990 BRAND NAME: BONE SCREW, CATALOG NUMBER: 00877502802 LOT NUMBER: 2960402 BRAND NAME: BIOLOX DELTA CERAMIC HEAD, CATALOG NUMBER: 010000661 LOT NUMBER:3442540 BRAND NAME: G7 ACETABULAR SHELL, CATALOG NUMBER:110024461 LOT NUMBER:599730 BRAND NAME: G7 DUAL MOBILITY, CATALOG NUMBER:XL-200144 LOT NUMBER: 332220 BRAND NAME: ACT ARTIC HD ARCOM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-02254, 0002648920-2019-00381. 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 REMAINS IMPLANTED IN THE PATIENT.

    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
    448933 BONE SCR 6.5X35 SELF-TAP PROSTHESIS, HIP MRA ZIMMER MANUFACTURING B.V. N/A 64190171

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization SEE H10 NARRATIVE