MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS-FLEX FXD MLD CD/1-2 10MM; PROSTHESIS, KNEE

Catalog Number	00596402210
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient began experiencing symptoms and presented at the clinic where radiological examination revealed osteolysis.The patient is currently undergoing further examination.A revision of the knee joint may be necessary.Due diligence is in progress for this event; to date no additional information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical product: stemmed tibial component precoat size 2 for cemented use only: catalog#00598002702, lot#64425375; lps flex femoral component-option for cemented use only size d left: catalog#00596801451, lot#64595008.G2: foreign: germany.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b1; b2; b4; b5; g3; h1; h2; h3; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was unable to be confirmed.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
Correspondence has indicated that the patient does not require further treatment or revision surgery.All available information has been provided.

• Brand Name: NEXGEN LPS-FLEX FXD MLD CD/1-2 10MM
• 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: 22841608
• Report Number: 0001822565-2025-03000
• Device Sequence Number: 4848974
• Product Code: JWH
• UDI-Device Identifier: 00889024211704
• UDI-Public: (01)00889024211704(17)271031(10)64541045
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/18/2026

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: 00596402210
• Device Lot Number: 64541045
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2019
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown