Brand Name | TAPERFILL HIP |
Type of Device | TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 9 |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd. |
austin TX 78758 5445 |
|
Manufacturer (Section G) |
ENCORE MEDICAL L.P. |
9800 metric blvd. |
|
austin TX 78758 5445 |
|
Manufacturer Contact |
teffany
hutto
|
9800 metric blvd. |
austin, TX 78758-5445
|
|
MDR Report Key | 6869916 |
MDR Text Key | 86347936 |
Report Number | 1644408-2017-00860 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 00888912078672 |
UDI-Public | (01)00888912078672 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130099 |
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 |
10/16/2017 |
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 | 08/03/2022 |
Device Model Number | 425-97-009 |
Device Catalogue Number | 425-97-009 |
Device Lot Number | 174R1067 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/05/2017
|
Initial Date FDA Received | 09/15/2017 |
Supplement Dates Manufacturer Received | 09/20/2017
|
Supplement Dates FDA Received | 10/18/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/08/2016 |
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 |
Treatment | 400-03-361,LOT 864B1214; 430-98-054,LOT 590G1142; 931-36-754,LOT 762N1939 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 60 YR |
|
|