MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP ADAPTIVE CS INSER IMPLANT SZ 4/2 LEFT; KNEE COMPONENT

Model Number	EAI4212L
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/14/2021
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, the patient was overextending.The femur and insert were revised.A revision femoral with augments and a stem extension were implanted along with a thicker insert.Left knee.Additional information received on 01/19/2021 from reliability engineer: product id's and lot numbers for products revised, date of original and revision surgery.Additional information received on 01/19/2021 from sales rep (b)(6): explanation about why the revision surgery was rescheduled from (b)(6) 2021 to (b)(6) 2021 (changed requested implant's size).

• Brand Name: EVOLUTIONMP ADAPTIVE CS INSER IMPLANT SZ 4/2 LEFT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11301122
• Report Number: 3010536692-2021-00063
• Device Sequence Number: 3368791
• Product Code: HRY
• UDI-Device Identifier: M684EAI4212L1
• UDI-Public: M684EAI4212L1
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: EAI4212L
• Device Catalogue Number: EAI4212L
• Device Lot Number: 1707230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/19/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/31/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention