BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM COCR BIOMET FEM HD +3 NK

    MDR report key: 7855947 · Received September 7, 2018

    Report

    Report Number
    3002806535-2018-01019
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    January 9, 2015
    Report Date
    September 7, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWY
    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). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN WARSAW, INDIANA MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042037. CONCOMITANT MEDICAL PRODUCTS: 22-301343 ARCOS CON SZ C STD 80MM HA 854650, 22-300918 ARCOS 18X190MM SPL TPR DIST HA 176110, UNKNOWN DOUBLE MOBILITY AVANTAGE CUP, UNKNOWN DOUBLE MOBILITY AVANTAGE INSERT, 00625006515 BONE SCREW SELF-TAPPING 6.5 MM DIA. 15 MM LENGTH 62566993, 00625006520 BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH 62256199, 00625006520 BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH 62748069 00625006540 BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH 62440464, 11-302144 ARCOS LATERAL TROCH BOLT 44MM 566380, 11-302102 ARCOS TROCH CLAW SMALL 100MM 286710, 120002 COCR TROCH CABLE 2.0MMX750MM 008130, 120010 COCR CABLE/SLEEVE SET 2.0MM 900490. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE SURGICAL OP NOTES WERE NOT PROVIDED. POST OPERATIVE X-RAY REVIEW SHOWS THE OVERALL FIT AND ALIGNMENT OF THE HARDWARE IS APPROPRIATE. OSTEOPENIA IS LIKELY PRESENT. NO SIGNS OF LOOSENING OR RADIOLUCENCY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND IDENTIFIED NO DEVIATIONS AND/OR ANOMALIES THAT RELATE TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED WITH THE INFORMATION 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 A RIGHT HIP REVISION SURGERY. SUBSEQUENTLY, THE PATIENT EXPERIENCED WOUND DEHISCENCE. PATIENT WAS TREATED WITH DEBRIDEMENT, CULTURES, AND PROPHYLACTIC ANTIBIOTICS WITH IN ONE MONTH POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697749 32MM COCR BIOMET FEM HD +3 NK PROSTHESIS, HIP KWY BIOMET UK LTD. N/A 3123536

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention