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

Model Number KTCCNP31

Device Problem Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to instability/wear of polyethylene component.Revision njr number: 5052592.Side: l.Primary asa: p2 - mild disease not incapacitating.

• Brand Name: ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 3+
• 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: 16751367
• MDR Text Key: 313409207
• Report Number: 3010536692-2023-00083
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP311
• UDI-Public: M684KTCCNP311
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K960617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KTCCNP31
• Device Catalogue Number: KTCCNP31
• Device Lot Number: 1487381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention