BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 56MM

    MDR report key: 7650688 · Received June 29, 2018

    Report

    Report Number
    0001825034-2018-04312
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    May 28, 2014
    Report Date
    February 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OPERATIVE NOTES RECEIVED. REVISION NOTES STATED THE PATIENT WAS REVISED DUE TO METALLOSIS AND ELEVATED METAL ION LEVELS. IT WAS NOTED THAT DURING THE REVISION LARGE PSEUDOTUMOR WAS REMOVED AND THAT METAL STAINING AND MILD CORROSION WAS PRESENT AT THE TAPER. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES WOULD CONTRIBUTE TO REPORTED EVENT. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET M2A HEAD ITEM#11-173662 LOT#040280. 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 - 2018 - 04313 - 3.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO UNKNOWN PRODUCT LOCATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IMPLANTED DATE - (B)(6) 2005. CONCOMITANT MEDICAL PRODUCTS: ITEM # UNKNOWN, UNKNOWN HEAD, LOT # UNKNOWN; ITEM # UNKNOWN, UNKNOWN TAPER ADAPTER, LOT # UNKNOWN; ITEM # UNKNOWN, UNKNOWN STEM, LOT # UNKNOWN. CONSUMER - ATTORNEY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04313; 0001825034 - 2018 - 04314.

    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. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO METALLOSIS, ELEVATED METAL IONS COBALT 6.0 & CHROMIUM 23.7. IT WAS NOTED THAT DURING THE REVISION LARGE PSEUDOTUMOR WAS REMOVED AND THAT METAL STAINING AND MILD CORROSION WAS PRESENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP REVISION SURGERY APPROXIMATELY 8.5 YEARS POST IMPLANTATION DUE TO MULTIPLE METAL ON METAL COMPLICATIONS. METAL COMPLICATIONS INCLUDE PAIN, INFLAMMATION, DAMAGE TO BONE AND TISSUE, LACK OF MOBILITY, LOOSENING, BONE FRACTURE, DISLOCATION, METALLOSIS, AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493558 M2A-38 CUP NON FLARED SZ 56MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 209700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R