MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POSTERIOR STABILIZED LEFT SIZE 11 PPS STANDARD FEMUR; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Pneumonia (2011)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that the patient was hospitalized two days post implantation for pneumonia, clostridioides difficile (c.Diff) colitis, and sepsis.Treated with oxygen, oral vancomycin, iv cefepime, oral flagyl, iv fluids were administered.After admission, the patient began developing recurrent fevers with no apparent cause.A ct revealed a pulmonary embolism and so the patient was started on iv heparin.The patient's outcome has not resolved and is ongoing.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D10 ¿ medical products: item #42511400810, lot #64188966; articular surface fixed bearing (ps) lft 10 mm; item # 42506607001, lot # 65897831; posterior stabilized lft sz 11 pps standard femur; item # 42535007501, lot # 66421913; 0a spiked keel lft size f osseoti tibia; item # 42540000035, lot # 66514572; all poly patella cemented 35 mm diameter.G2: study: persona osseoti pmcf (b)(6).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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to update additional information in sections b4, b5, e1, e2, e3, g3, g6, h2, and h11.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Pneumonia: 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.Pneumonia is a procedural related complication resulting from intubation during the procedure and is considered a hospital-acquired condition.C.Difficile: c.Diff is a well known hospital acquired bacterial infection of the intestines that causes copious and severe watery diarrhea as well as intestinal inflammation (colitis).Treatment includes rehydration, iv antibiotics, and medical observation.Pe: procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Deep vein thrombosis (blood clot), or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operatively to prevent dvt formation.Despite prophylaxis, dvts can still develop which can then break free within the vessel and occlude or block the blood flow in the lungs, known as a pulmonary embolism (pe).As the complaint indicated, post-operative complications occurred, and medical intervention was required for treatment.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, d4, d6a, g3, g6, h2, h3, h4, h6, and h11.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: POSTERIOR STABILIZED LEFT SIZE 11 PPS STANDARD FEMUR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19415475
• Report Number: 0001822565-2024-01768
• Device Sequence Number: 8540166
• Product Code: JWH
• UDI-Device Identifier: 00889024631793
• UDI-Public: (01)00889024631793(17)330604(10)65897831
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 08/27/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42506607001
• Device Lot Number: 65897831
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 05/29/2024; 08/01/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 06/24/2024; 08/27/2024
• Date Device Manufactured: 06/12/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: White