BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X42MM

    MDR report key: 8698397 · Received June 13, 2019

    Report

    Report Number
    0001825034-2019-02586
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    May 25, 2019
    Report Date
    September 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS CONFIRMED WITH MEDICAL RECORDS RECEIVED. THE FOLLOWING WERE NOTED IN THE MEDICAL RECORDS: -PAINLESS DRAINING WOUND WHICH BEGAN APPROXIMATELY 2 WEEKS PRIOR TO I & D ¿ -OLD HEMATOMA ENCOUNTERED -NO EVIDENCE OF INFECTION ¿ -DID NOT EXTEND INTO DEEP FASCIA DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DATE OF BIRTH: (B)(6) 1948. (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: 110024463, G7 DUAL MOBILITY LINER 42MM E, LOT: 592180; PART: 110010244, G7 OSSEOTI 3 HOLE SHELL 52MM E, LOT: 6382214; PART: 51-101080, TPRLC 133 FP TYPE1 PPS HO 8.0, LOT: 2941040; PART: EP-200148, ACT ARTIC E1 HIP BRG 28X42MM, LOT: 026970; PART: 650-1055, CER BIOLOXD OPTION HD 28MM, LOT: 2945915. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: LINER: 0001825034-2019-02583, CUP: 0001825034-2019-02584, STEM: 0001825034-2019-02585, BEARING: 0001825034-2019-02586.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT THA. THE PATIENT LATER DEVELOPED DRAINAGE FROM THE WOUND SITE AND AN OLD HEMATOMA WAS ENCOUNTERED. SUBSEQUENTLY 3 MONTHS LATER, THE PATIENT'S WOUND WAS DEBRIDED AND IRRIGATED WITHOUT SIGNS OF INFECTION NOTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491602 ACT ARTIC E1 HIP BRG 28X42MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 026970

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R