MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® PRIMARY FEMORAL SIZE 5 RIGHT NONPOROUS; KNEE COMPONENT

Model Number KFTCNP5R

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient was revised due to peri-prosthetic fracture.Revision njr number: (b)(4), side: r, primary asa: p3 - incapacitating systemic disease.The product kpon38sp, advance® onlay all-poly patella 38mm single peg was not revised.

• Brand Name: ADVANCE® PRIMARY FEMORAL SIZE 5 RIGHT NONPOROUS
• 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: 14356975
• MDR Text Key: 291404888
• Report Number: 3010536692-2022-00170
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: M684KFTCNP5R1
• UDI-Public: M684KFTCNP5R1
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K972626
• 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: 07/07/2022

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: KFTCNP5R
• Device Catalogue Number: KFTCNP5R
• Device Lot Number: 68622049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/22/2022
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 07/07/2022
• 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