Brand Name | EXPRT HIP |
Type of Device | EXPRT REVISION HIP, STANDARD OFFSET PROXIMAL BODY, 75MM |
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 | 12532662 |
MDR Text Key | 273340185 |
Report Number | 1644408-2021-01040 |
Device Sequence Number | 1 |
Product Code |
KWZ
|
UDI-Device Identifier | 00190446153825 |
UDI-Public | (01)00190446153825 |
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 |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/04/2022 |
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 Model Number | 495-00-075 |
Device Catalogue Number | 495-00-075 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/20/2021
|
Initial Date FDA Received | 09/27/2021 |
Supplement Dates Manufacturer Received | 11/12/2021
|
Supplement Dates FDA Received | 01/04/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 400-03-402 LOT UNKNOWN.; 400-03-402 LOT UNKNOWN |
Patient Outcome(s) |
Required Intervention;
Other;
|
Patient Age | 71 YR |
Patient Sex | Female |