Brand Name | FEMORAL HEAD/NECK IMPACTOR |
Type of Device | PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
MDR Report Key | 9187070 |
MDR Text Key | 162481173 |
Report Number | 1020279-2019-03632 |
Device Sequence Number | 1 |
Product Code |
MEH
|
Combination Product (y/n) | N |
PMA/PMN Number | K113789 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
12/11/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/14/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 71360093 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/06/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|