BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38 MM ONE-PIECE CUP 38MM X 52 O.D.

    MDR report key: 5989981 · Received September 30, 2016

    Report

    Report Number
    0001825034-2016-03891
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    June 16, 2014
    Report Date
    June 13, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-08656 / 1825034-2016-03891). EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - M2A 38MM FEMORAL HEAD CATALOG#: 11-173662 LOT#: 788450, BI-METRIC FEMORAL STEM CATALOG#: 162311 LOT#: 02063690. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 CONTRIBUTE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-03891, 0001825034-2017-03936.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE THEY UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY ELEVEN YEARS POST-IMPLANTATION DUE TO ALLEGATIONS OF SQUEAKING, PAIN, DRY COUGH, RHONCHUS AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORTS NOTED GREYISH METAL INFUSED TISSUE WAS FOUND DURING THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641785 M2A 38 MM ONE-PIECE CUP 38MM X 52 O.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 644660

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R