MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 3 STANDA; KNEE COMPONENT

Model Number KTCCNP30

Device Problem Loss of Osseointegration (2408)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2024

Event Type  Injury  

Event Description

Allegedly, the patient was diagnosed with radiology.Evident loosening of the prosthesis was detected, the tibial base was replaced.The initial implantation was performed in 2015.First revision: it was detected shortly after implantation that there was infection and an insert change was performed.Pe was not firmly attached to the tibial component as intended, but became detached from it.As a result, there was wear of the underside of the insert with polyethylene granulomas.There were polyethylene granulomas throughout the joint and complete loosening of the prosthesis.The joint was reconstructed with a complex coupled, modular, stem-guided prosthesis and all granulomas were removed in approximately 3 hours of revision surgery.The explants were given to the patient: product id: kimp312r advance® ii medial pivot tibial insert sz 3 right 12mm / lot no.: 1687317/ qty: (b)(4).Product id: kftcnp3r advance® primary femoral size 3 right nonporous / lot no.: 1707334/ qty: (b)(4).Product id: ktccnp30 advance® ii cocr tibial base nonporous sz 3 standard/ lot no.: 1644600/ qty:(b)(4).

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 3 STANDA
• Type of Device: 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: 19146657
• MDR Text Key: 340629319
• Report Number: 3010536692-2024-00266
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP301
• UDI-Public: M684KTCCNP301
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K960617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Device Operator: Health Professional
• Device Model Number: KTCCNP30
• Device Catalogue Number: KTCCNP30
• Device Lot Number: 1644600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male