MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 5+ 10MM LEFT; KNEE COMPONENT

Model Number EIS5P10L

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the patient has been suffering from restricted mobility and a feeling of tension in the area of the left knee joint for about a year.In the previous year, several punctures were carried out without evidence of the pathogen.In june, an x-ray examination showed a femoral component fracture, which is why the indication for a component change was made.Additional information received on 09/02/2021: component eis5p10l added reporting resultant wear.(b)(6).Basg ref.: (b)(4).

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 5+ 10MM 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: 12520518
• MDR Text Key: 273758292
• Report Number: 3010536692-2021-00528
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS5P10L1
• UDI-Public: M684EIS5P10L1
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS5P10L
• Device Catalogue Number: EIS5P10L
• Device Lot Number: 1586444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2021
• Date Manufacturer Received: 09/02/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 45 KG