Brand Name | EVOLUTION® TIBIA |
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 | 8023708 |
MDR Text Key | 125638361 |
Report Number | 3010536692-2018-01282 |
Device Sequence Number | 1 |
Product Code |
HRY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
10/31/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Device Model Number | ETKS-CC6L |
Device Catalogue Number | ETKS-CC6L |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 10/03/2018 |
Initial Date Manufacturer Received |
10/03/2018
|
Initial Date FDA Received | 10/31/2018 |
Supplement Dates Manufacturer Received | 10/03/2018
|
Supplement Dates FDA Received | 01/08/2019
|
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 | 56 YR |
|
|