MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 4 STANDA; KNEE COMPONENT

Model Number	KTCCNP40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, pain mainly at night, itching when falling asleep and at night, constant swelling of the knee, although less than two years ago.Some allergies were detected during the operation: dust, pollen, chloramphenicol, penicillin intolerance, and aspirin intolerance.Allergies detected in tests performed for constant pain and swelling of the knee (b)(6) 2025: potassium dichromate, 2-bromo-2-nitropop.1.3, isopropylphenol, paraphenylenediamine, lanolin, propolis.Patient suffered this reaction 6 years.The surgical procedure is unclear.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
The provided documentation supports that this patient has experienced allergy-related symptoms and swelling of the of the knee it was reported that the patient has been experiencing this reaction for more than 6 years.Mpo received clinical documentation in czech with reported allergies that were identified from lab tests.Some of the allergies are associated with nature and medicine, with others associated with compounds.This patient was implanted with cobalt-chromium alloy implants for the femur and tibial base, and a polyethylene bearing for the tibial insert.These implants undergo cleaning and sterilization operations that have been validated to result in endotoxin and test of sterility that meet the necessary standards for acceptability.As documented in the mpo knee systems package insert, document reference (b)(4), swelling and inflammation is a known possible risk of any surgical procedure, including total knee arthroplasty.Mpo is unable to draw conclusions with the reported allergic complications and the mpo implants.Review of all quality documentation associated with the subject manufacturing lots shows that all products met the established acceptance criteria, and mpo has not received any other complaint reports for the subject manufacturing lots.Based on the available information, mpo is unable to provide conclusions regarding the potential of production contribution to the reported complications.Furthermore, mpo has not identified any trends for allergic reactions and associated swelling or inflammation for these product families.Mpo will continue to monitor for this complaint type through complaint tracking.
Additional Manufacturer Narrative
Additional manufacturer narrative: updated (section b.3: (b)(6) 2019 incident.Section d.6b: (b)(6) 2025 explant yr).

• Brand Name: ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 4 STANDA
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 23633207
• Report Number: 3010536692-2025-00376
• Device Sequence Number: 21177438
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP401
• UDI-Public: M684KTCCNP401
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K960617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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: Other
• Device Model Number: KTCCNP40
• Device Catalogue Number: KTCCNP40
• Device Lot Number: 1773875
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/28/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 80 KG