Brand Name | EPIK KNEE |
Type of Device | EPIK UNI FEMUR 6 L MEDIAL/R LATERAL |
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 | 3840648 |
MDR Text Key | 4662752 |
Report Number | 1644408-2014-00324 |
Device Sequence Number | 1 |
Product Code |
HRY
|
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 |
05/21/2014 |
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 | 02/28/2015 |
Device Catalogue Number | 200-01-106 |
Device Lot Number | 53982290 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/20/2014
|
Initial Date FDA Received | 05/30/2014 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/12/2014
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/12/2009 |
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 |
Treatment | (B)(4), LOT 327B1001; (B)(4), LOT A1000002 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 70 YR |
|
|