Brand Name | STEM IMPACTOR ROD |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED |
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 |
sarah
freestone
|
1450 brooks road |
memphis
, TN 38116
|
0447940038
|
|
MDR Report Key | 8746916 |
Report Number | 1020279-2019-02596 |
Device Sequence Number | 1 |
Product Code | JDI |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,HEALTH |
Reporter Occupation |
OTHER HEALTH CARE PROFESSIONAL
|
Type of Report
| Initial |
Report Date |
07/30/2019 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 06/30/2019 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device Catalogue Number | 71364011 |
Device LOT Number | 09JM69371 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 07/05/2019 |
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 06/18/2019 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|