BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A ACETABULAR SYSTEM

    MDR report key: 6041928 · Received October 19, 2016

    Report

    Report Number
    0001825034-2016-04194
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 27, 2016
    Report Date
    April 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - M2A ACETABULAR CUP CATALOG#: RD118858 LOT#: 821070, BI-METRIC FEMORAL STEM CATALOG#: X180314 LOT#: 134470. IT HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET. 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: 0001825034-2016-04194 AND 0001825034-2017-02605.

    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. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY 12 YEARS POST-IMPLANTATION DUE TO PAIN AND DISCOMFORT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR A HIP REVISION PROCEDURE DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691961 M2A ACETABULAR SYSTEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 183460

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R