MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION(TM) MP FEMORAL COMPONENT; KNEE COMPONENT

Model Number EFSR-N4PL

Device Problem Insufficient Information (3190)

Patient Problem Neck Stiffness (2434)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trend will be evaluated.

Event Description

(b)(4).Allegedly, patient suffering from flexion contracture.(b)(4).(originally captured on (b)(4)) additional information received: (b)(6) 2017.Allegedly the patient was suffering from vasovagal episode (left) additional information received 09/14/2018: stiffness of knee noted on (b)(6) 2017, rom was 15-60 degrees.On follow up (b)(6) 2017, stiffness still noted and rom was 0 degrees with push and 85 degrees.Patient was booked for surgery on that follow-up.Surgery on (b)(6) 2017 of manipulation of knee under anesthesia.Follow-ups indicate physiotherapy and medication ongoing.

• Brand Name: EVOLUTION(TM) MP FEMORAL COMPONENT
• 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: 7949406
• MDR Text Key: 123192984
• Report Number: 3010536692-2018-01272
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EFSR-N4PL
• Device Catalogue Number: EFSR-N4PL
• Device Lot Number: 1653475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/14/2018
• Date Manufacturer Received: 09/14/2018
• 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
• Patient Age: 57 YR
• Patient Weight: 73