Brand Name | X3 TRIATHLON INSERT CR#2 9MM |
Type of Device | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO |
Manufacturer (Section D) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
mahwah NJ 07430 |
|
Manufacturer (Section G) |
STRYKER ORTHOPAEDICS-LIMERICK |
raheen business park |
|
limerick NA |
|
Manufacturer Contact |
rita
intorrella
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 6272895 |
MDR Text Key | 65917740 |
Report Number | 0002249697-2017-00317 |
Device Sequence Number | 1 |
Product Code |
MBH
|
UDI-Device Identifier | 07613327046410 |
UDI-Public | (01)07613327046410(11)160203(17)210228(10)LEW705 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K141056 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/28/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/24/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2021 |
Device Catalogue Number | 5530G209 |
Device Lot Number | LEW705 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/11/2017 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/01/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/03/2016 |
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) |
Other;
|
Patient Age | 55 YR |
|
|