Brand Name | USP II HUMERAL HEAD 48/19 |
Type of Device | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
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 | 10096431 |
MDR Text Key | 193729420 |
Report Number | 1220246-2020-01851 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 00888867057821 |
UDI-Public | 00888867057821 |
Combination Product (y/n) | N |
Reporter Country Code | AU |
PMA/PMN Number | K071032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
05/28/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/28/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2018 |
Device Model Number | USP II HUMERAL HEAD 48/19 |
Device Catalogue Number | AR-9148-19P |
Device Lot Number | 2501344508 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/04/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/24/2014 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|