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

Model Number ETPK-N4SL

Device Problem Insufficient Information (3190)

Patient Problem Loss of Range of Motion (2032)

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

Ae# (b)(4).Additional information received 09/14/2018: allegedly, patient suffering from flexion contracture.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.Ae# (b)(4).(originally captured on (b)(4)) additional information received: 11/08/2017.Allegedly the patient was suffering from vasovagal episode (left).

• Brand Name: EVOLUTION(TM) MP TIBIAL BASE
• 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: 7962698
• MDR Text Key: 123666279
• Report Number: 3010536692-2018-01298
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ETPK-N4SL
• Device Catalogue Number: ETPK-N4SL
• Device Lot Number: 1636553
• 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