Brand Name | IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL |
Type of Device | - PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
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 | 9473632 |
MDR Text Key | 176412278 |
Report Number | 1220246-2019-01494 |
Device Sequence Number | 1 |
Product Code |
KRR
|
UDI-Device Identifier | 00888867034273 |
UDI-Public | 00888867034273 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K160461 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/16/2019 |
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 | IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL |
Device Catalogue Number | AR-501-UFLD |
Device Lot Number | 10195016 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/27/2019
|
Initial Date FDA Received | 12/16/2019 |
Was Device Evaluated by Manufacturer? |
No
|
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;
|
|
|