BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A MOD HEAD STD NK

    MDR report key: 7032119 · Received November 15, 2017

    Report

    Report Number
    0001825034-2017-09843
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    August 11, 2017
    Report Date
    May 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. REVISION OP NOTES INDICATE PATIENT HAVING DRAINAGE THROUGH HIS HIP SURGICAL INCISION SITE. PATIENT HAVING HIP PROBLEMS AND INCREASED PAIN BEFORE REVISION. IT WAS EVALUATED AND FOUND OUT TO BE MRSA. IT WAS NOTED THAT PATIENT'S COBALT LEVEL WAS ELEVATED BUT THE CHROMIM WAS NOT. SURGEON NOTED BLACK MATERIAL ALONG THE TRUNNION CONSISTENT WITH METAL CORROSION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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)(6). CONCOMITANT: 15-105004, M2A-TAPER LINER SZ 41/32, 552400; 13-103209, TAPERLOC POR RED/LAT 17.5X155, 085710; 15-103688, M2A-T UNIV 2-HOLE SHL SZ 41/58, 780070; 13-103209, TAPERLOC POR RED/LAT 17.5X155, 085710; 103537, TI LOW PROFILE SCREW 6.5X50MM, 980780. CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2017 - 09844. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED HIP INFECTION APPROXIMATELY 12 YEARS POST-IMPLANTATION. PATIENT PRESENTED WITH PAIN AND WOUND DRAINAGE. PATIENT WAS DIAGNOSED WITH MRSA AND UNDERWENT ASPIRATION PROCEDURE AND ANTIBIOTIC TREATMENT. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURE DUE TO (B)(6), ELEVATED COBALT LEVEL, AND SUSPECTED METALLOSIS/TRUNNIONOSIS. DURING THE REVISION, YELLOW FLUID WITH CLOUDY CONSISTENCY, BLACK MATERIAL ALONG THE TRUNNION CONSISTENT WITH METAL CORROSION, AND WELL-FIXED STEM WERE NOTED. ALL COMPONENTS WERE REMOVED FROM THE PATIENT AND CEMENT SPACERS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812425 32MM M2A MOD HEAD STD NK PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 523970

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R