MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN; PROSTHESIS, KNEE

Catalog Number	00598004702
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883); Arthrofibrosis (4885)
Date of Event	05/21/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure approximately 2 years post implantation due to pain.During the revision the femoral component was found stable and was retained.The tibial component was found loosened medially with underlying bone showing worn eaten appearance due to several bone cavities.The tibial components were revised.There was also presence of clear synovial fluid and abundant fibrous tissue.No intraop or postop complications were identified.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).D10: pn: 00596404010, ln: 62103538 nexgen lps flex poly 10mm.G2 foreign - italy.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h6.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records; lot identification was not provided.This device is used for treatment.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the reported item.However, as the lot number is unknown, an additional review could not be performed.Medical records provided and reviewed state that the patient underwent an initial left total knee arthroplasty on for osteoarthritis.The procedure was reported as uncomplicated.The implanted components included a nexgen tibial component, nexgen lps femoral component, nexgen lps flex polyethylene insert, and palacos cement.Subsequently, on (b)(6) 2014, the patient underwent revision of the left knee at the same hospital, due to pain approximately two years after the initial implantation.Intraoperative findings noted abundant fibrous tissue, and a stable, well-positioned femoral component that was retained.The tibial component was found to be loosened medially, with underlying bone demonstrating a worm-eaten appearance with several bone cavities, and the tibial component and polyethylene insert were revised.The knee was reported to be stable with correct patellar tracking following revision.No intraoperative or postoperative complications were identified.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Complaint is confirmed.D4: attempts have been made to gather all product identification information and no further information has been provided.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
No further event information is available at the time of this report.

• Brand Name: NEXGEN
• 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: 24143559
• Report Number: 0001822565-2026-00218
• Device Sequence Number: 8859712
• Product Code: JWH
• UDI-Device Identifier: 00889024217614
• UDI-Public: (01)00889024217614(17)34727(10)64942055
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 00598004702
• Device Lot Number: 64942055
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• 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 Weight: 100 KG