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

Model Number EIS5-S12R

Device Problem Insufficient Information (3190)

Patient Problem Neck Stiffness (2434)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient suffering from flexion contracture of her knee.Additional information received 01/12/2018.Upon first follow-up post-op, subject was described as "v.Stiff".Subject was given a cylindrical cast on (b)(6) 2016.Cast was removed on (b)(6) 2016.Subject as given jas brace.Subject was given botox injections.Subject has one rigorous physiotherapy.Upon follow-up on (b)(6) 2017, surgeon recommended r knee scope and lysis of scar tissue.

Manufacturer Narrative

Update incident description and explant date.

Event Description

(b)(4).Allegedly the patient is suffering from flexion contracture of the knee.(b)(4).Additional information received on 10/26/2017: allegedly the patient underwent surgery of the knee, including arthroscopy, extensive synovectomy, quadriceplasty, and manipulation under anesthesia.On april 24, 2017.Patient was also tested for allergens (b)(4).Additional information received on 04/03/2018: allegedly the patient was revised due to flexion contracture and allergic reaction to metals on (b)(6) 2017.Tibial component was retained.

• Brand Name: EVOLUTION(TM) MP CS INSERT
• 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: 7259184
• MDR Text Key: 99587274
• Report Number: 3010536692-2018-00103
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS5-S12R
• Device Catalogue Number: EIS5-S12R
• Device Lot Number: 1488460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2018
• Date Manufacturer Received: 01/12/2018
• 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: 55 YR
• Patient Weight: 58