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 Reaction (2414)

Event Date 11/09/2016

Event Type  Injury  

Event Description

Allegedly the patient was suffering from flexion contracture/allergic reaction to the material (right).(b)(6).Additional information received 01/12/2018.Subject was previously diagnosed with flexion contracture and allergic reaction to materials.Subject was seen in ore-operative unit for assessment, then had surgery and revised components on (b)(6) 2017.Tibial component was retained.Vancomycin was used in cement.Subject was discharged on (b)(6) 2017.

Manufacturer Narrative

After the initial report it was determined that this report is a duplicate of mdr #3010536692-2018-00103.Please void the initial report.

• 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: 7259189
• MDR Text Key: 99589056
• Report Number: 3010536692-2018-00099
• 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
• 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: 59