BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TPR HI CARBON 41/32MM LNR

    MDR report key: 8873535 · Received August 8, 2019

    Report

    Report Number
    0001825034-2019-03466
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    June 25, 2019
    Report Date
    October 9, 2019
    Manufacturer
    .
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 10-104052, M2A TAPER CUP, 254250; 11-163689, M2A TAPER CARBON HEAD, 404460; UNKNOWN STEM, UNKNOWN PART AND LOT. REPORT SOURCE (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K042037. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE SURGEON DID NOT APPROVE OF THE RETURN. 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: 0001825034-2019-03465, 0001825034-2019-03467.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO SUSPICION OF PSEUDOTUMOR. 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
    667509 M2A TPR HI CARBON 41/32MM LNR PROSTHESIS, HIP KWY . N/A 409130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R