Brand Name | EXPRT HIP |
Type of Device | EXPRT REVISION HIP, DISTAL STEM, 17X130 |
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 |
kiersten
soderman
|
9800 metric blvd |
austin, tx 78758-5445
|
|
MDR Report Key | 12853487 |
MDR Text Key | 281129851 |
Report Number | 1644408-2021-01236 |
Device Sequence Number | 1 |
Product Code |
KWZ
|
UDI-Device Identifier | 00190446154006 |
UDI-Public | (01)00190446154006 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K161610 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/19/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/22/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 495-17-130 |
Device Catalogue Number | 495-17-130 |
Device Lot Number | 563U1040 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 10/27/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/30/2021 |
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 868B1344; 495-01-065 LOT 545U1128 |
Patient Outcome(s) |
Disability;
Required Intervention;
|
Patient Age | 71 YR |
Patient Sex | Male |