BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM SCREW LOW PROFILE

    MDR report key: 10837153 · Received November 13, 2020

    Report

    Report Number
    0001825034-2020-04046
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    November 17, 2004
    Report Date
    November 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM NUMBER: RD118860, ITEM NAME: M2A CUP, LOT NUMBER: 011150; ITEM NUMBER: X180314, ITEM NAME: BI-METRIC STEM, LOT NUMBER: 308810; ITEM NUMBER: 11-173665, ITEM NAME: M2A HEAD, LOT NUMBER: 527970. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. FACILITIES HAVE DISCHARGE CRITERIA THAT PATIENTS MUST MEET POST SURGICAL PROCEDURE. IF THE DISCHARGE CRITERIA ARE NOT MET, THEN THE PATIENT WILL BE KEPT UNTIL THEY ARE STABLE FOR DISCHARGE, AND FOR THEIR SAFETY. THE DELAYED/PROLONGED HOSPITALIZATION IS NOT ABNORMAL, AS SIDE EFFECTS FROM ANESTHESIA ARE COMMON AND TYPICALLY RESOLVE WITHIN 24-48 HOURS. 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 PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY. DURING THE IMMEDIATE POST-OP PERIOD, IT WAS NOTED THAT THE PATIENT EXPERIENCED HYPOTENSION REQUIRING A BLOOD TRANSFUSION. NO FURTHER COMPLICATIONS WERE NOTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300919 TITANIUM SCREW LOW PROFILE PROSTHESIS, EXTREMITY MBF ZIMMER BIOMET, INC. N/A 503370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other