Brand Name | GLOBAL UNITE STD STEM SZ 8 |
Type of Device | GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
warsaw IN 46582 0988 |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg ringaskiddy co. |
|
cork |
EI
|
|
Manufacturer Contact |
kara
ditty-bovard
|
1210 ward avenue |
west chester, PA 19380-XXXX
|
6107428552
|
|
MDR Report Key | 8573498 |
MDR Text Key | 143831136 |
Report Number | 1818910-2019-92275 |
Device Sequence Number | 1 |
Product Code |
HSD
|
UDI-Device Identifier | 10603295004042 |
UDI-Public | 10603295004042 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101996 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/09/2019 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 110008100 |
Device Lot Number | 8627714 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/09/2019
|
Initial Date FDA Received | 05/02/2019 |
Supplement Dates Manufacturer Received | 06/03/2019
|
Supplement Dates FDA Received | 06/03/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/15/2017 |
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 | 76 YR |