MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 6; PROSTHESIS, KNEE

Catalog Number	00598004702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown - unknown femoral component - unknown.Unknown - unknown articular surface - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left knee surgery.Subsequently, the patient has been experiencing pain and a ''clicking / clunking'' noise in the joint with swelling around the knee.The initial surgeon suggested the patient undergo a genicular nerve ablation which the patient did including a year of pt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.Attempts have been made to gather all product identification information and no further information has been provided.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Radiographs were provided and reviewed by a healthcare professional.A definitive root cause cannot be determined.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.
Event or Problem Description
It was further reported that the patient was also experiencing a decreased range of motion.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b7; d1; d2; d4; d10; e1; g1; g3; g4; g6; h1; h2; h4; h6.D10: 00599401691 - left size f cemented option femoral component femoral plastic cap must be removed prior to implantation - (b)(6), 00599404017 - 17mm height size e,f with locking screw green articular surface use with femoral e,f / screw enclosed do not discard - (b)(6), 00598801622 - long 22mm diameter 130mm length sharp fluted stem extension combined length 175mm - (b)(6), 00598801522 - 22mm diameter 75mm length sharp fluted stem extension combined length 120mm - (b)(6), 00597206535 - all poly petella standard cemented size 35 mm diameter 9.0 mm thickness (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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; d2; d4; g1; g3; g6; h1; h2; h4; h6; h10 the event can be confirmed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a healthcare professional.Review of the records state that the patient was experiencing pain, swelling and clicking and clunking in the joint.Patient is also experiencing great difficulty and stiffness while attempting to bend past 90 degrees.Root cause remains unchanged.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.

• Brand Name: NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 6
• 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: 23027977
• Report Number: 0001822565-2025-03374
• Device Sequence Number: 18498751
• Product Code: JWH
• UDI-Device Identifier: 00889024217614
• UDI-Public: (01)00889024217614(17)320812(10)J7322169
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2026

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 Catalogue Number: 00598004702
• Device Lot Number: J7322169
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 09/15/2025; 02/10/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 09/16/2025; 10/07/2025; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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 H10; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 79 KG