BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR BIOMET FEM HD -3 NK

    MDR report key: 7851686 · Received September 6, 2018

    Report

    Report Number
    3002806535-2018-01060
    Event Type
    Injury
    Date Received
    September 6, 2018
    Date of Event
    February 12, 2016
    Report Date
    September 6, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 22-301302 ARCOS CON SZ B STD 60MM HA 303880, 22-300916 ARCOS 16X190MM SPL TPR DIST HA 379520, PT-106056 REGEN/RNGLC+ MULTI 56MM SZ 24 389700, EP-105894 EPOLY RLC 36MM 10DEG SZ24 SZ24 437480, 103531 TI LOW PROFILE SCREW 6.5X20MM 3106140, 103532 BM ACET LP DOME SCW TI S/TAP DIA6.5X25MM 3127304, 103533 TI LOW PROFILE SCREW 6.5X30MM 3154823, 350806 2.0 MM SS CABLE/SLEEVE COMBO 283490, 350806 2.0 MM SS CABLE/SLEEVE COMBO 203530, 350806 2.0 MM SS CABLE/SLEEVE COMBO 111410. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). G4: THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL RIGHT HIP SURGERY ON AN UNKNOWN DATE AND WAS REVISED DUE TO LOOSENING (B)(6) 2014. SUBSEQUENTLY PATIENT EXPERIENCED PROBLEMS WALKING ABOUT, PROBLEMS WASHING OR DRESSING, MODERATE PAIN (MAY TAKE ASPIRIN), A MODERATE LIMP, MODERATE TROUBLE GETTING IN OR OUT OF THE CAR, MODERATE DIFFICULTY PUTTING ON SOCKS, NOTED IT WAS IMPOSSIBLE TO SHOP, EXTREMELY DIFFICULT TO CLIMB STAIRS, MODERATELY PAINFUL TO STAND UP, AND UNABLE TO PERFORM USUAL ACTIVITIES AT 3 YEAR FOLLOW UP VISIT ON 12 FEB 2016. THE PATIENT WAS ALSO USING 2 CRUTCHES OR A WALKER AT THE 3 YEAR VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692552 36MM COCR BIOMET FEM HD -3 NK PROSTHESIS, HIP HRY BIOMET UK LTD. N/A 2754109

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other