Brand Name | QUICK-CONNECT HANDLE (2/PK) |
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-MAHWAH |
325 corporate drive |
|
mahwah NJ 07430 |
|
Manufacturer Contact |
brian
lauro
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 6775319 |
MDR Text Key | 82088573 |
Report Number | 0002249697-2017-02415 |
Device Sequence Number | 1 |
Product Code |
MBH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123486 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/08/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 8000-0000 |
Device Lot Number | RD6W050 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/09/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/12/2017 |
Initial Date FDA Received | 08/08/2017 |
Supplement Dates Manufacturer Received | 09/11/2017
|
Supplement Dates FDA Received | 10/08/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/02/2012 |
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;
|
|
|