Brand Name | SROM NRH TIB PLAT ASSY SM 21MM |
Type of Device | LPS AND S-ROM : KNEE TIBIAL INSERT |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46582 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46581-0988
|
5743725905
|
|
MDR Report Key | 7396698 |
MDR Text Key | 104419951 |
Report Number | 1818910-2018-56695 |
Device Sequence Number | 1 |
Product Code |
KRO
|
UDI-Device Identifier | 10603295178989 |
UDI-Public | 10603295178989 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K011810 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
03/13/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/15/2014 |
Device Catalogue Number | 621613 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/13/2018 |
Initial Date FDA Received | 04/04/2018 |
Date Device Manufactured | 12/08/2009 |
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) |
Required Intervention;
|
Patient Age | 68 YR |