MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM SERIES A PAT STD 31 3 PEG; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adult Respiratory Distress Syndrome (1696); Hypoxia (1918); Pneumonia (2011); Septic Shock (2068); Respiratory Failure (2484)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: vanguard cr ilok fem-lt 65 catalog #: 183028 lot #: j6689690; vg crl mono-lck brg10x67 catalog #: 189240 lot #: 617200.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02690, 0001825034 - 2021 - 02698, 0001825034 - 2021 - 02699.Investigation incomplete.
Event or Problem Description
It was reported that an initial left total knee arthroplasty was performed.Two days post operatively, the patient was readmitted for hypoxia, pneumonia, respiratory failure, septic shock, and ards.The patient was reintubated 17 days later and discharged 3 days after that.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
It was reported the patient developed pneumonia within two days postop leading to septic shock and respiratory failure.Respiratory cultures were positive for pantoea septica and yeast with gram stains positive for yeast and moderate white blood cells.Pantoea bacteria are found in the intestinal tract of humans.Yeast is a common oral inhabitant that can create respiratory complications after general anesthesia when the endotracheal tube pushes the flora into the respiratory tract.The patient was ultimately intubated for three days until the complication resolved.The patient also had a concurrent urine culture positive for e.Coli.Additionally, the patient has preexisting cardiac complications, obstructive sleep apnea, and obesity; all of which place increased stress on the respiratory system and put the patient at increased risk for postop respiratory complications.Procedural-related complications are influenced by the type of surgery, patients preexisting comorbid state, and perioperative management.Pneumonia is a well-known postoperative complication that typically requires medical intervention and hospitalization for more aggressive medical management.During the immediate post-operative period for a period of 2 hours, the protective reflexes are depressed and the patient can aspirate.Typically, the reason for postoperative pneumonia is the aspiration of subglottic secretions containing bacteria.Once the bacteria enters the respiratory tract, they can replicate if the conditions are right and advance into aspiration pneumonia.Pneumonia is a procedural-related complication resulting from intubation during the procedure.The root cause is attributed to non-device related factors.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARCOM SERIES A PAT STD 31 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12519490
• Report Number: 0001825034-2021-02699
• Device Sequence Number: 924198
• Product Code: JWH
• UDI-Device Identifier: 00880304431317
• UDI-Public: (01)00880304431317(17)250109(10)277660
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K040770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2025
• Device Model Number: N/A
• Device Catalogue Number: 184764
• Device Lot Number: 277660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 111