BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TAPER LINER

    MDR report key: 10133349 · Received June 9, 2020

    Report

    Report Number
    0001825034-2020-02266
    Event Type
    Injury
    Date Received
    June 9, 2020
    Date of Event
    May 11, 2020
    Report Date
    August 18, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; G4; H2; H3; H4; H6 REPORTED EVENT IS UNABLE TO BE DETERMINED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. X-RAYS WERE PROVIDED AND REVIEWED BY A THIRD PARTY HCP NOTING ANATOMIC ALIGNMENT OF THE LEFT HIP AND OSTEOPENIA. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-163660 ¿ M2A HEAD ¿ 014030; 15-104048 ¿ M2A TAPER SHELL ¿ 157270; UNKNOWN STEM ¿ UNKNOWN PART AND LOT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-02267.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 17 YEARS POST IMPLANTATION DUE TO INCREASE METAL ION LEVELS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598533 M2A TAPER LINER PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 785480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10