Brand Name | GLOBAL ADVANTAGE HUM HD 44X15 |
Type of Device | SHOULDER HEAD/GLENOSPHERE |
Manufacturer (Section D) |
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 |
no.299 changyang st |
suzhou industrial park |
suzhou, jiangsu 2151 2-6 |
CH 21512-6 |
|
Manufacturer (Section G) |
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 |
no.299 changyang st |
suzhou industrial park |
suzhou, jiangsu 2151 2-6 |
CH
21512-6
|
|
Manufacturer Contact |
steve
dowell
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743714918
|
|
MDR Report Key | 4232437 |
MDR Text Key | 4976490 |
Report Number | 1818910-2014-31312 |
Device Sequence Number | 1 |
Product Code |
KWT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK984541 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/14/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/06/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/18/2017 |
Device Catalogue Number | 112844000 |
Device Lot Number | D12011005 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/13/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/27/2011 |
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) |
Required Intervention;
|
Patient Age | 81 YR |
Patient Weight | 59 |