Brand Name | OXINIUM FEM HD 12/14 28MM +8 |
Type of Device | PROSTHESIS,HIP,SEMICONSTRAIND,METL/CERAMIC/POLYMR,CEMNTDORNONPOROUS,UNCEMNTD |
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 |
markus
poettker
|
1450 brooks road |
memphis, TN 38116
|
|
MDR Report Key | 7138075 |
MDR Text Key | 95490979 |
Report Number | 1020279-2017-01320 |
Device Sequence Number | 1 |
Product Code |
LZO
|
UDI-Device Identifier | 03596010474179 |
UDI-Public | 03596010474179 |
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K021673 |
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 |
03/15/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/21/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/13/2017 |
Device Catalogue Number | 71342808 |
Device Lot Number | 07LM11519 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/11/2017 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/16/2007 |
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;
|
Patient Age | 54 YR |
|
|