Brand Name | HIP JOINT FEMORAL |
Type of Device | SHELL, BIPOLAR, MODULAR, ENCORE, SIZE50 |
Manufacturer (Section D) |
ENCORE MEDICAL L. P. |
9800 metric blvd |
austin TX 78758 5445 |
|
MDR Report Key | 10541482 |
MDR Text Key | 207232744 |
Report Number | 1644408-2020-00863 |
Device Sequence Number | 1 |
Product Code |
KWY
|
UDI-Device Identifier | 00888912077415 |
UDI-Public | (01)00888912077415 |
Combination Product (y/n) | N |
PMA/PMN Number | K953510 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup |
Report Date |
11/13/2020 |
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 | 06/17/2022 |
Device Model Number | 412-02-050 |
Device Catalogue Number | 412-02-050 |
Device Lot Number | 997B1085 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/17/2020 |
Initial Date FDA Received | 09/16/2020 |
Supplement Dates Manufacturer Received | 10/15/2020
|
Supplement Dates FDA Received | 11/13/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 497-28-000, LOT 629C1565.; D111-18-1402, LOT 7D15E.; 497-28-000, LOT 629C1565; D111-18-1402, LOT 7D15E |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 68 YR |
|
|