Brand Name | SMARTSET GMV 40G US EO |
Type of Device | BONE CEMENT : BONE CEMENT |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
warsaw IN 46582 0988 |
|
Manufacturer (Section G) |
DEPUY CMW - 9610921 |
cornford rd |
|
blackpool IN FY4 4 QQ |
UK
FY4 4QQ
|
|
Manufacturer Contact |
kara
ditty-bovard
|
1210 ward avenue |
west chester, PA 19380
|
6103142063
|
|
MDR Report Key | 8137861 |
MDR Text Key | 129480719 |
Report Number | 1818910-2018-77403 |
Device Sequence Number | 1 |
Product Code |
LOD
|
UDI-Device Identifier | 10603295174295 |
UDI-Public | 10603295174295 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K081163 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
11/12/2018 |
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 Catalogue Number | 545050501 |
Device Lot Number | 8068940 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/12/2018
|
Initial Date FDA Received | 12/06/2018 |
Supplement Dates Manufacturer Received | 12/10/2018
|
Supplement Dates FDA Received | 12/11/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/29/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 69 YR |
Patient Weight | 100 |
|
|