Brand Name | UNK |
Type of Device | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL |
Manufacturer (Section D) |
ARTHREX, INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
Manufacturer (Section G) |
ARTHREX, INC. |
1370 creekside boulevard |
|
naples FL 34108 1945 |
|
Manufacturer Contact |
|
MDR Report Key | 16129756 |
MDR Text Key | 306983549 |
Report Number | 1220246-2023-06087 |
Device Sequence Number | 1 |
Product Code |
JWH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K133342 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Study,Literature |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
01/10/2023 |
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
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/19/2022
|
Initial Date FDA Received | 01/10/2023 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|