MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II POST STAB TIBIAL INSERT SIZE 2 10MM; KNEE COMPONENT

Model Number KIPS2210

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to peri-prosthetic fracture.No revised: part id kpontp35, advance onlay all poly patella 35mm tripeg, lot 29792865, qty 1.Revision njr number: (b)(4), side: r, primary asa: p2 - mild disease not incapacitating.

Manufacturer Narrative

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

Manufacturer Narrative

The additional information from reliability engineering is that he considered that this event should be changed to "no complaint stated" and there is no complaint against the device.Please void this report.

• Brand Name: ADVANCE® II POST STAB TIBIAL INSERT SIZE 2 10MM
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 13402007
• MDR Text Key: 284800368
• Report Number: 3010536692-2022-00031
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684KIPS22101
• UDI-Public: M684KIPS22101
• 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,Followup
• Report Date: 02/08/2022

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: Other
• Device Model Number: KIPS2210
• Device Catalogue Number: KIPS2210
• Device Lot Number: 88692091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2022
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention