Brand Name | REFLECTION |
Type of Device | CERAMIC FEMORAL HEAD PROSTHESIS |
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 |
melanie
travis
|
1450 brooks road |
memphis, TN 38116
|
9013996233
|
|
MDR Report Key | 4818412 |
MDR Text Key | 5919764 |
Report Number | 1020279-2015-00351 |
Device Sequence Number | 1 |
Product Code |
LZO
|
Combination Product (y/n) | N |
PMA/PMN Number | NOT AVAILABL |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative,company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/08/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/04/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 76539170 |
Device Lot Number | 14KT47170 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 05/08/2015 |
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;
|
Patient Age | 60 YR |
Patient Weight | 68 |
|
|