Brand Name | X-ALT HIP |
Type of Device | LINER 10 DEG. HOODED NEU, MP8 HXE-PLUS, 36MM |
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 | 7105031 |
MDR Text Key | 94418404 |
Report Number | 1644408-2017-01146 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 00888912100175 |
UDI-Public | (01)00888912100175 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130365 |
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 |
12/21/2017 |
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 | 10/20/2021 |
Device Model Number | 932-36-754 |
Device Catalogue Number | 932-36-754 |
Device Lot Number | 814N1949 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/22/2017
|
Initial Date FDA Received | 12/11/2017 |
Supplement Dates Manufacturer Received | 12/13/2017
|
Supplement Dates FDA Received | 12/21/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/26/2016 |
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 | 400-03-363, LOT 868B1168 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 69 YR |
|
|