Brand Name | PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY |
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-ALAMEDA |
1600 harbor bay parkway |
suite 200 |
alameda CA 94502 |
|
Manufacturer Contact |
keyla
colon
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 5947808 |
MDR Text Key | 54626630 |
Report Number | 0002249697-2016-02929 |
Device Sequence Number | 1 |
Product Code |
MBH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K110533 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,other |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
08/17/2016 |
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 Catalogue Number | TR7100-R |
Device Lot Number | 12167034 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/17/2016 |
Initial Date FDA Received | 09/13/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 11/16/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/14/2012 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 2249697-11/19/12-013-R |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 64 YR |
Patient Weight | 90 |
|
|