BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 60ODX54ID

    MDR report key: 7587718 · Received June 11, 2018

    Report

    Report Number
    0001825034-2018-03740
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    August 30, 2017
    Report Date
    October 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. REVIEW OF OPERATIVE NOTES FROM THE REVISION SURGERY NOTE THAT PATIENT UNDERWENT A RIGHT HIP REVISION OF THE ACETABULAR CUP AND FEMORAL HEAD WITH EXCISION OF PSEUDOTUMOR. THE PATIENT HAS HAD INCREASING PAIN FOR THE PAST FEW MONTHS. MRI REVEALS LATERAL FLUID COLLECTION CONSISTENT WITH PSEUDOTUMOR. THE MAGNUM HEAD WAS REMOVED AND THE ACETABULUM WAS IMPACTED. IT WAS FOUND THAT IT DID MOVE WITH FORCEFUL IMPACTION. THE CUP WAS THEN REMOVED AND THE SOFT TISSUE STAINING AND METALLOSIS AROUND THE RIM WAS REMOVED WITH MINIMAL BACKSIDE STAINING NOTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 139264, TAPER INSERT, LOT # 535720, ITEM # 157454, FEMORAL HEAD, LOT # 056200, ITEM # 21-123205, FEMORAL STEM, LOT # 112710. LEGAL NOTIFICATION. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03740, 0001825034-2018-03741.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO ALLEGATIONS OF PAIN, METALLOSIS, AND CUP LOOSENING. REVISION OP NOTES INDICATE GRAY STAINING UNDERNEATH THE DEEP FASCIA. THERE WAS NO SIGNIFICANT METALLOSIS OR CHROMIUM OXIDE STAINING ON THE TRUNNION. THE ACETABULUM WAS THEN IMPACTED AFTER CLEANING THE TISSUE. IT WAS FOUND THAT IT DID MOVE WITH FORCEFUL IMPACTION. THERE WERE NO SIGNIFICANT DEFECTS NOTED OF THE ACETABULUM. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429804 M2A-MAGNUM PF CUP 60ODX54ID HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 810290

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R