BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD

    MDR report key: 8800974 · Received July 17, 2019

    Report

    Report Number
    0001825034-2019-03068
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    February 27, 2018
    Report Date
    May 3, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING PATIENT EXPERIENCING PAIN AND DARK MATERIAL FOUND WITHIN THE SYNOVIUM. DHR 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04239.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D9; G3; H2; H3; H6 H6: COMPONENT CODE MECHANICAL (G04) ¿ HEAD VISUAL INSPECTION OF THE RETURNED HEAD FOUND WEAR LINES ON THE OD OF THE CUP ALONG WITH SCUFF MARKS. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART: 157444, M2A-MAGNUM MOD HD SZ 44MM, LOT: 189150, PART: 139256, M2A-MAGNUM 42-50 TPR INSRT STD, LOT: 872110, PART: US157850, M2A-MAGNUM PF CUP 50ODX44ID, LOT: 330620, PART: X12-171310, INTEGRAL/X POR RED PROX 10MM, LOT: 087460. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: HEAD: 0001825034-2019-03068, NECK: 0001825034-2019-03067.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY, ALMOST TEN YEARS LATER, THE PATIENT WAS REVISED DUE TO A PAINFUL LEFT HIP. DURING THE REVISION, DARK MATERIAL WAS NOTED WITHIN THE SYNOVIUM. HEAD AND NECK REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592452 M2A-MAGNUM MOD HEAD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 189150

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R