MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION; PROSTHESIS, KNEE

Catalog Number	00598603701
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial knee surgery.Approximately 5 years post-op, the patient reported experiencing pain and underwent a bone scan that revealed lucency indicating tibial loosening.A revision surgery has been scheduled.Attempts have been made and all available information has been provided.
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.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: a1; a3a; b4; b5; d2; d10; e1; e2; e3; g1; g2; g3; g4; g6; h1; h2.D10: 00576401551 femoral component option for cemented use only size e left 64411102.00596403212 articular surface size ef 12 mm height ''use with plate 3, 64541086.00597206529 all poly petella standard cemented size 29 mm diameter 8.0 mm thickness 63932359.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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 attempts have been made to gather all product identification information and no further information has been provided.The event cannot be confirmed.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.Medical records were not provided.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
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; h3; h4; h6 the device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause remain unchanged: 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.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION
• 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: 23827397
• Report Number: 0001822565-2025-04561
• Device Sequence Number: 13078470
• Product Code: JWH
• UDI-Device Identifier: 00889024218833
• UDI-Public: (01)00889024218833(17)290225(10)J6472586
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/12/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00598603701
• Device Lot Number: J6472586
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 01/12/2026; 05/12/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/29/2025; 01/14/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2019
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female