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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint effusion (4849)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: femur trabecular metal cruciate retaining (cr) catalog # 42502806602 lot # 65588161.Articular surface use with plate catalog # 00595205012 lot # 64458794.All poly petella catalog # 00597206538 lot # 65736639.Unk cement catalog # unk lot # unk.Multiple mdr reports were filled for this event: 0001822565-2023-01495.0001822565-2023-01500.0002648920-2023-00106 hemarthrosis is a condition of articular bleeding, that is into the joint cavity.This can occur after an injury, in bleeding disorders such as hemophilia, side effect from blood thinners, or after surgery of one of your joints.Patients will typically present with pain, swelling and a decreased range of motion of the involved joint.Symptoms of hemarthrosis can be treated at home while waiting for the joint to heal using rice method.Rice stands for rest, ice, compression and elevation.An aspiration is the removal of fluid from a joint for treatment or diagnostic purposes aspiration is typically done in a joint for diagnostic purposes.If aspiration is mentioned, with no other documentation to support, why aspiration was conducted or what the results were of the aspiration; it can be implied that it was conducted for diagnostic purposes as the joint was exhibiting signs such as pain, inflammation, or swelling.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
It was reported patient experienced a pop in the posterior knee, pain and an effusion from hemarthrosis seventeen days post implantation.Patient underwent an in office aspiration, followed by a second aspiration, due to a recurrent effusion.Aspirations were completed without complication.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: TIBIAL TRAY FIXED BEARING
• 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: 17073504
• Report Number: 0001822565-2023-01499
• Device Sequence Number: 5886495
• Product Code: JWH
• UDI-Device Identifier: 00889024208285
• UDI-Public: (01)00889024208285(17)321125(10)65594098
• 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: 2023
• 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
• Report Date (Section B): 06/06/2023

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: 00595405701
• Device Lot Number: 65594098
• 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: 05/17/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White