BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 NON FLARED ONE-PIECE CUP

    MDR report key: 6386792 · Received March 8, 2017

    Report

    Report Number
    0001825034-2017-01404
    Event Type
    Injury
    Date Received
    March 8, 2017
    Date of Event
    August 29, 2016
    Report Date
    September 28, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE ASSOCIATED REPORT 0001825034 - 2017 - 01405.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01405, 0001825034-2017-07317. CONCOMITANT MEDICAL PRODUCTS: M2A 38 MM MOD HD+6 MM NK NO SKRT CATALOG#: 11-173664 LOT#: 924460, TAPERLOC POR LAT FMRL 9X137 CATALOG#: 11-103203 LOT#: 670390. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AND SHOULD NOT HAVE BEEN REPORTED. THE INITIAL REPORT SHOULD BE VOIDED AS IT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S HIP ARTHROPLASTY WAS REVISED AFTER 7 YEARS DUE TO PAIN, ELEVATED LEVELS OF COBALT AND CHROMINUM AND METALLOSIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    (B)(6)2015 COBALT 3.7 UG/L. (B)(6)2015 COLBALT 2.8 UG/L. (B)(6)2015 CHROMIUM 2.9. DURING THE REVISION SURGERY SEROSAL LINING WAS NOTED TO HAVE A SLIGHT GRAY TINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171181 M2A-38 NON FLARED ONE-PIECE CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 915420

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R