BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD M UNI BRNG B4 LM/RL

    MDR report key: 19278187 · Received May 9, 2024

    Report

    Report Number
    0001825034-2024-01186
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    August 29, 2021
    Report Date
    May 7, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    UDI-DI
    00880304180611
    PMA / PMN Number
    K042093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IT WAS REPORTED THAT 6 DAYS POSTOP, A PATIENT WITH CONSIDERABLE CARDIOVASCULAR COMORBIDITIES DEVELOPED PNEUMONIA AND HYPOTENSION. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBIDITIES, AND PERIOPERATIVE MANAGEMENT. PNEUMONIA IS A WELL-KNOWN POSTOPERATIVE COMPLICATION THAT TYPICALLY REQUIRES MEDICAL INTERVENTION AND POSSIBLY EVEN HOSPITALIZATION FOR MORE AGGRESSIVE MEDICAL MANAGEMENT. WITHIN A TWO-HOUR POSTOPERATIVE WINDOW, THE PROTECTIVE REFLEXES OF THE OROPHARYNGEAL PASSAGES ARE DEPRESSED, AND THE PATIENT CAN ASPIRATE. THE REASON FOR POSTOPERATIVE PNEUMONIA IS TYPICALLY DUE TO ASPIRATION OF SUBGLOTTIC SECRETIONS CONTAINING BACTERIA. ONCE THE BACTERIA ENTER THE RESPIRATORY TRACT, THEY CAN REPLICATE AND ADVANCE INTO ASPIRATION PNEUMONIA. THE MICROORGANISM CAUSING PNEUMONIA CAN ENTER THE BLOODSTREAM OR THE BODY'S RESPONSE TO THE INFECTION CAN BE EXCESSIVE, RESULTING IN HYPOTENSION. PATIENT THAT HAVE KNOWN HISTORY OF RESPIRATORY OR LUNG DISEASES SUCH AS COPD, ASTHMA, OR ARE IMMUNE SUPPRESSED ARE AT INCREASED RISK FOR DEVELOPING THIS COMPLICATION. PNEUMONIA IS A PROCEDURAL RELATED COMPLICATION RESULTING FROM INTUBATION DURING THE PROCEDURE AND IS CONSIDERED A HOSPITAL-ACQUIRED CONDITION. AS THE COMPLAINT INDICATES, A POSTOPERATIVE COMPLICATION OF PNEUMONIA AND HYPOTENSION DEVELOPED, AND MEDICAL INTERVENTION WOULD BE REQUIRED FOR TREATMENT. ADDITIONAL ASSOCIATED PRODUCTS. US154700 VANGUARD M UNI BRNG B4 LM/RL LOT# 478980. 161468 OXFORD TWIN-PEG CMNTD FEM SM PMA LOT# 881780. 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

    IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY AND DEVELOPED PNEUMONIA AND HYPOTENSION WITHIN A WEEK OF THE PROCEDURE. NO FURTHER DISCUSSION OR INFORMATION REGARDING INTERVENTION OR OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478229 VANGUARD M UNI BRNG B4 LM/RL PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 478980 00880304180611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other