BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HEAD COMPONENT

    MDR report key: 6653019 · Received June 20, 2017

    Report

    Report Number
    0001825034-2017-03836
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    January 24, 2006
    Report Date
    January 15, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT PRODUCTS: M2A 38MM MOD HD -3MM NK/ PN 11-173661/ LN 129670, TAPERLOC POR LAT FMRL 12.5X145/ PN 11-103206/ LN 197970. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF IT 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: 0001825034-2017-03837.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION HIP PROCEDURE AND APPROXIMATELY TWO WEEKS POST OP WAS REVISED DUE TO INFECTION. CUP, HEAD AND STEM WERE REMOVED FOR APPROXIMATELY 8 - 10 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433843 M2A 38MM MOD HEAD COMPONENT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 129670 

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R SEE H10 NARRATIVE