Brand Name | SL-PLUS MIA STEM WITH TI/HA |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS AG |
oberneuhofstrasse 10d |
baar 5001 |
SZ 5001 |
|
Manufacturer (Section G) |
SMITH & NEPHEW ORTHOPAEDICS AG |
schachenallee 29 |
|
aarau 5001 |
SZ
5001
|
|
Manufacturer Contact |
|
MDR Report Key | 6566510 |
MDR Text Key | 75143612 |
Report Number | 9613369-2017-00029 |
Device Sequence Number | 1 |
Product Code |
LZO
|
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | K122296 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
06/26/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/15/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/21/2017 |
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) |
Disability;
|
Patient Age | 65 YR |
|
|