BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T UNIV 2-HOLE SHL SZ 41/58

    MDR report key: 10842354 · Received November 16, 2020

    Report

    Report Number
    0001825034-2020-04102
    Event Type
    Injury
    Date Received
    November 16, 2020
    Date of Event
    October 27, 2020
    Report Date
    December 18, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. REVIEW OF INITIAL OPERATIVE NOTES SHOWS NO COMPLICATIONS AND THE CUP COMPONENT IN GOOD POSITION WITH GOOD BONE COVERAGE, SOLIDLY FIXED. THE DHR WAS REVIEWED AN 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 DEVICES: 15-105004 - M2A TAPER LINER - 883700; 11-163669 - M2A HEAD - 175650; X180315 - BI-METRIC STEM - 161110. 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 AND A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 04103, 0001825034 - 2020 - 04104.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 15 YEARS POST IMPLANTATION DUE TO PAIN FROM METAL-ON-METAL COMPLICATIONS. THE CUP AND HEAD WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT. 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
    1311201 M2A-T UNIV 2-HOLE SHL SZ 41/58 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 534460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R