MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL TRAY FIXED BEARING SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544); Joint effusion (4849)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00989, 0001822565-2023-00990, and 0000002648920-2023-00074.D10 medical products: femur trabecular metal cruciate retaining (cr) standard porous, catalog#: 42502806201, lot#: 64584412; articular surface size green/c-h 14 mm height, catalog#: 00595204014, lot#: 64590072; all poly patella standard cemented size 35 mm diameter 9.0 mm thickness, catalog#: 00597206535, lot#: 65270040.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent left total knee arthroplasty.Subsequently, approximately nine months post-implantation, the patient had recurrent hemarthrosis leading to left knee arthroscopy, debridement, lysis, and adhesions.During the procedure fluid was sent to microbiology for cell count and gram stain culture.No intraoperative complications were reported.No additional information or outcomes provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.The synovial membrane (synovium) encloses each joint and secretes fluid to allow joints to move freely.When the synovium is irritated by debris or pathogens, it over-secrets fluid causing local pain/tenderness, inflammation, swelling, and warmth, often resulting in mobility difficulties.Synovitis is treated with steroid injections to reduce the pain and inflammation or by arthroscopic or open synovectomy.Hemarthrosis is a condition of articular bleeding, that is into the joint cavity.This can occur after and injury, bleeding disorder, or surgery.Common symptoms include pain, swelling, and decreased range of motion of the involved joint.Hemarthrosis can be treated at home using the rice method rest, ice, compression, and elevation however, when patient do not respond to conservative measures embolization maybe performed.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b6, g3, g6, h2, h11.
Event or Problem Description
It was reported that the patient developed recurrent hemarthrosis and adhesions approximately nine (9) months following left knee arthroplasty.The patient was treated with debridement and lysis of adhesions at that time.The patient continued to experience pain and swelling and underwent a left geniculate artery embolization for the hemiarthrosis approximately six (6) weeks later.The patient continued to experience ongoing stiffness and was further treated with iliotibial band release and excision of scar tissue approximately three (3) months later.No additional patient consequences were reported.Operative reports from the procedures identified no intraoperative complications.

• Brand Name: TIBIAL TRAY FIXED BEARING SIZE 5
• 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: 16750939
• Report Number: 0001822565-2023-00991
• Device Sequence Number: 11582343
• Product Code: JWH
• UDI-Device Identifier: 00889024208261
• UDI-Public: (01)00889024208261(17)300331(10)64648785
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/19/2025

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: 00595404701
• Device Lot Number: 64648785
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 04/10/2023; 07/27/2023; 01/24/2025
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/04/2023; 08/03/2023; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2020
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White