MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP TIB KEELED NONPOR SIZE 4 STANDARD LEF; KNEE COMPONENT

Model Number ETPKN4SL

Device Problem Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient underwent l tkr on (b)(6) 2018, primary surgeon has since retired.Revised on (b)(6) 2023 due to tibial loosening.Cement and implant were solid, but patient reported pain.Revised with evolution revision tibial base and a thicker insert.

• Brand Name: EVOLUTION®MP TIB KEELED NONPOR SIZE 4 STANDARD LEF
• 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: 16656121
• MDR Text Key: 312431596
• Report Number: 3010536692-2023-00036
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN4SL1
• UDI-Public: M684ETPKN4SL1
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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: ETPKN4SL
• Device Catalogue Number: ETPKN4SL
• Device Lot Number: 1755895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 05/10/2023
• 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
• Patient Age: 92 YR
• Patient Sex: Female