Brand Name | REF THREADED HOLE COVER |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS |
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 | 7184219 |
MDR Text Key | 97048193 |
Report Number | 1020279-2018-00044 |
Device Sequence Number | 1 |
Product Code |
MBL
|
UDI-Device Identifier | 03596010197634 |
UDI-Public | 03596010197634 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K070756 |
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 |
03/06/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/14/2018 |
Device Catalogue Number | 71336500 |
Device Lot Number | 08MM13629 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/04/2018 |
Initial Date FDA Received | 01/11/2018 |
Supplement Dates Manufacturer Received | 01/04/2018
|
Supplement Dates FDA Received | 03/06/2018
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/16/2008 |
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;
|
|
|