Brand Name | BIPOLAR HIP |
Type of Device | SHELL, BIPOLAR, MODULAR, ENCORE, SIZE47 |
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 | 12618968 |
MDR Text Key | 276446044 |
Report Number | 1644408-2021-01095 |
Device Sequence Number | 1 |
Product Code |
KWY
|
UDI-Device Identifier | 00888912077385 |
UDI-Public | (01)00888912077385 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K953510 |
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 |
10/11/2021 |
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 | 412-02-047 |
Device Catalogue Number | 412-02-047 |
Device Lot Number | 993B1138 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/29/2021 |
Initial Date FDA Received | 10/12/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/19/2019 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 76 YR |
|
|