MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® ADAPTIVE STEMMED CS; KNEE COMPONENT

Model Number	EFXSNP6L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, surgeon had to do additional surgery on a patient because the femoral component and the stem came uncoupled.Additional information received from surgeon on 8/17/2022: patient had a previous supracondylar femur fracture years ago which had healed in a valgus position.This led to arthritis of the knee.Because of this situation we chose to perform a distal femoral osteotomy to address the malunion and a total knee arthroplasty to address the arthritis.The plan was that the stemmed implant should maintain the correction gained by the osteotomy.The patient did well initially but then noted increasing pain and increasing valgus angulation of the knee.X-rays showed increasing valgus alignment and the stem was coming uncoupled from the femoral component.On (b)(6) 2022, surgery to correct this was a reduction and placement of a lateral locking plate on the femur to maintain alignment and allow healing of the osteotomy.The femoral component and the stem were left in place.The femoral component maintained its fixation on the distal fragment and the stem maintained its position in the im canal.The angulation occurred at the connection between the two.Surgeon also stated: ".The connection between the femoral component and a stem have not maintained a strong connection.I have a friend who is an engineer and used to own a mechanical testing company.He states a morse taper is a very reliable connection.It should not come apart easily and sometimes requires special tools to disengage the joint.".

• Brand Name: EVOLUTION® ADAPTIVE STEMMED CS
• Common Device Name: 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: 15355398
• Report Number: 3010536692-2022-00313
• Device Sequence Number: 12343039
• Product Code: JWH
• UDI-Device Identifier: M684EFXSNP6L1
• UDI-Public: M684EFXSNP6L1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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
• Operator of Device: Other
• Device Model Number: EFXSNP6L
• Device Catalogue Number: EFXSNP6L
• Device Lot Number: 1610457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown