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

Model Number EAI4212L

Device Problem Unstable (1667)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

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

Event 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
• 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: 11301122
• MDR Text Key: 230964670
• Report Number: 3010536692-2021-00063
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EAI4212L1
• UDI-Public: M684EAI4212L1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EAI4212L
• Device Catalogue Number: EAI4212L
• Device Lot Number: 1707230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/19/2021
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention