Brand Name | PROFEMUR® Z STEM |
Type of Device | HIP COMPONENT |
Manufacturer (Section D) |
MICROPORT ORTHOPEDICS INC. |
5677 airline rd. |
arlington TN 38002 |
|
Manufacturer (Section G) |
MICROPORT ORTHOPEDICS INC. |
5677 airline rd. |
|
arlington TN 38002 |
|
Manufacturer Contact |
|
5677 airline road |
arlington, TN 38002
|
9018674771
|
|
MDR Report Key | 8505391 |
MDR Text Key | 141645667 |
Report Number | 3010536692-2019-00636 |
Device Sequence Number | 1 |
Product Code |
LPH
|
Combination Product (y/n) | N |
PMA/PMN Number | K021346 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Type of Report
| Initial,Followup |
Report Date |
04/11/2019 |
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 |
Other
|
Device Model Number | PHA0-0236 |
Device Catalogue Number | PHA0-0236 |
Device Lot Number | T09128538 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 03/25/2019 |
Initial Date Manufacturer Received |
03/25/2019
|
Initial Date FDA Received | 04/11/2019 |
Supplement Dates Manufacturer Received | 03/25/2019
|
Supplement Dates FDA Received | 07/23/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 37 YR |
|
|