Brand Name | TRITANIUM BPLATE TRIATHLON S4 |
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 |
IE
NA
|
|
Manufacturer Contact |
collin
neitzel
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 9859476 |
MDR Text Key | 184917452 |
Report Number | 0002249697-2020-00572 |
Device Sequence Number | 1 |
Product Code |
MBH
|
UDI-Device Identifier | 07613327041491 |
UDI-Public | 07613327041491 |
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 |
Report Date |
03/20/2020 |
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 Model Number | 5536-B-400 |
Device Catalogue Number | 5536B400 |
Device Lot Number | CTD38408 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/20/2020 |
Initial Date FDA Received | 03/20/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/19/2019 |
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;
|
Patient Age | 56 YR |
Patient Weight | 103 |