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

Model Number	EFXSNP5L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
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, when revising a femoral component with a stem, surgeon removed the femoral component but the stem remained in the femur and had to be removed separately.Additional information received from surgeon on 8/17/2022: "patient had prior partial knee arthroplasty that had loosened.Revision to total knee was performed including use of stems to provide more stability to implants.Patient had difficulty regaining full extension.Posterior capsular release was performed.Limited extension persisted, so on 10-23-2018 revision of the femoral component was performed.The femoral component was removed and the stem stayed in place in the im canal and had to be removed separately." 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: 15355750
• Report Number: 3010536692-2022-00315
• Device Sequence Number: 14775642
• Product Code: JWH
• UDI-Device Identifier: M684EFXSNP5L1
• UDI-Public: M684EFXSNP5L1
• 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: 2018
• Device Explanted Year: 2018
• 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: EFXSNP5L
• Device Catalogue Number: EFXSNP5L
• Device Lot Number: 1610455
• 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