Brand Name | R3 36MM ID US CRMC LINER 52MM |
Type of Device | PROSTH, HIP, SEMI-CONST, METAL/CERAMIC/CERAMIC/METAL, CEMENT OR UNCEMENT |
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 |
sarah
freestone
|
1450 brooks road |
memphis, TN 38116
|
0447940038
|
|
MDR Report Key | 8787667 |
MDR Text Key | 150957444 |
Report Number | 1020279-2019-02669 |
Device Sequence Number | 1 |
Product Code |
MRA
|
UDI-Device Identifier | 00885556021552 |
UDI-Public | 00885556021552 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PO30022 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/02/2019 |
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 Catalogue Number | 71338952 |
Device Lot Number | 09FT53137 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/17/2019
|
Initial Date FDA Received | 07/14/2019 |
Supplement Dates Manufacturer Received | 06/17/2019
|
Supplement Dates FDA Received | 12/02/2019
|
Was Device Evaluated by Manufacturer? |
No
|
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;
|
|
|