MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD TWIN-PEG CMNTD FEM SM PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pneumonia (2011)
Date of Event	08/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had an initial left unicompartmental knee arthroplasty and developed pneumonia and hypotension within a week of the procedure.No additional information is available.
Additional Manufacturer Narrative
(b)(4).D10: us154700 vanguard m uni brng b4 lm/rl lot# 478980, unknown cement lot# unknown.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h11.It was reported that six 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.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: OXFORD TWIN-PEG CMNTD FEM SM PMA
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19357485
• Report Number: 3002806535-2024-00184
• Device Sequence Number: 11711714
• Product Code: NRA
• UDI-Device Identifier: 05019279438228
• UDI-Public: (01)05019279438228(17)310527(10)881780
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 161468
• Device Lot Number: 881780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White