BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR FEMORAL STEM PRESS-FIT

    MDR report key: 11819986 · Received May 13, 2021

    Report

    Report Number
    0001822565-2021-01330
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    July 6, 2016
    Report Date
    May 13, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024132658
    PMA / PMN Number
    K182678
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00784801400, M/L TAPER KINECTIV NECK, 61956654. 00875705802, CONTINUUM SHELL, 63290513. UNKNOWN LINER, UNKNOWN PART AND LOT. 00877504002, BIOLOX HEAD, 2823276. IT IS EXPECTED THAT A WOUND HEALS IN STAGES AND SHOULD BE OF NORMAL APPEARANCE RELATED TO THE TIMEFRAME SINCE THE INCISION WAS MADE. A SURGICAL WOUND SHOULD BE WELL APPROXIMATED WITHOUT REDNESS, WARMTH, SWELLING AND/OR PURULENT DRAINAGE FOR THE DURATION OF ITS HEALING. IT MAY BE RED, HAVE DRAINAGE, ADDITIONAL PAIN, WARMTH AND SWELLING AS WELL AS HEALING TIME MAY BE DELAYED. AS REPORTED THE PATIENT'S SURGICAL WOUND SITE/INCISION HAD SOME ABNORMAL OR UNEXPECTED REDNESS. THIS DEVIATION SIGNIFIES AN ALTERATION IN THE WOUND HEALING PROCESS. THE PATIENT HAD SEVERAL COMORBIDITIES SUCH AS ELEVATED BMI, CARDIOVASCULAR, AND LIVER DISEASE THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2021 - 01331, 0001822565 - 2021 - 01332, 0001822565 - 2021 - 01333.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO PHYSICIAN APPROXIMATELY 2 WEEKS POST INITIAL RIGHT HIP PROCEDURE WITH LATERAL REDNESS IN A WELL-APPROXIMATED, ALMOST HEALED INCISION. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS AND INSTRUCTED TO RETURN IN ONE WEEK FOR A FOLLOW UP. UPON RETURN, IT WAS NOTED THAT THE INCISION WAS COMPLETELY HEALED. NO FURTHER COMPLICATIONS WERE REPORTED CONCERNING THE INCISION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715684 MODULAR FEMORAL STEM PRESS-FIT PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63346813 00889024132658

    Patients

    Seq Age Sex Outcome Treatment
    1 Other