Brand Name | GLOBAL ADVANTAGE CTA HD 48X23 |
Type of Device | TOTAL SHOULDER PROSTHESIS |
Baseline Brand Name | GLOBAL ADVANTAGE CTA HD 48X23 |
Baseline Generic Name | SHOULDER PROSTHESIS |
Baseline Catalogue Number | 112865040 |
Baseline Device Family | GLOBAL ADVANTAGE SHOULDER HEAD |
Baseline Device 510(K) Number | K000575 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
No
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | NA |
Date First Marketed | 03/10/2000 |
Manufacturer (Section F) |
DEPUY ORTHOPAEDICS, INC. |
700 orthopaedic dr. |
warsaw IN 46581 0988 |
|
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. |
700 orthopaedic dr. |
warsaw IN 46581 0988 |
|
Manufacturer Contact |
hans
kusserow, mgr
|
700 orthopaedic drive |
warsaw
, IN 46581-0988 |
(574)
372
-7416
|
|
Device Event Key | 453228 |
MDR Report Key | 464288 |
Event Key | 439965 |
Report Number | 1818910-2003-00343 |
Device Sequence Number | 1 |
Product Code | HSD |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Distributor
|
Reporter Occupation |
Physician
|
Remedial Action |
Other
|
Type of Report
| Initial |
Report Date |
05/07/2003 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 06/06/2003 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 112865040 |
Device LOT Number | W42DC1001 |
Was Device Available For Evaluation? |
Yes
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 05/07/2003 |
Event Location |
Hospital
|
Date Manufacturer Received | 05/07/2003 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 01/01/2003 |
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|