Brand Name | EMP 13 STEM PRIMARY HO |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks road |
|
memphis TN 38116 |
|
Manufacturer Contact |
robert
rust
|
1450 brooks road |
memphis, TN 38116
|
|
MDR Report Key | 6655609 |
MDR Text Key | 78014876 |
Report Number | 1020279-2017-00451 |
Device Sequence Number | 1 |
Product Code |
MEH
|
UDI-Device Identifier | 03596010561497 |
UDI-Public | 03596010561497 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K042127 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,litera |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/03/2017 |
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 Catalogue Number | 71291302 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/22/2017 |
Initial Date FDA Received | 06/20/2017 |
Supplement Dates Manufacturer Received | 05/22/2017
|
Supplement Dates FDA Received | 10/03/2017
|
Was Device Evaluated by Manufacturer? |
No
|
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) |
Hospitalization;
Required Intervention;
|
|
|