Brand Name | EPIK KNEE |
Type of Device | INSERT, ONLAY TIBIAL, EPIK, SIZE45X9 |
Manufacturer (Section D) |
ENCORE MEDICAL, L.P. |
9800 metric blvd. |
austin TX 78758 |
|
Manufacturer (Section G) |
ENCORE MEDICAL, L.P. |
9800 metric blvd. |
|
austin TX 78758 |
|
Manufacturer Contact |
teffany
hutto
|
9800 metric blvd. |
austin, TX 78758-5445
|
5128346255
|
|
MDR Report Key | 6197329 |
MDR Text Key | 63053568 |
Report Number | 1644408-2016-01029 |
Device Sequence Number | 1 |
Product Code |
HRY
|
UDI-Device Identifier | 00888912116145 |
UDI-Public | (01)00888912116145 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K020741 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/24/2017 |
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 |
Health Professional
|
Device Expiration Date | 07/08/2021 |
Device Catalogue Number | 340-45-009 |
Device Lot Number | 334B1030 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/22/2016
|
Initial Date FDA Received | 12/21/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/24/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/14/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 57 YR |
|
|