Brand Name | GLOBAL UNITE HEAD 48X18 ECC |
Type of Device | GLOBAL UNITE IMPLANTS : HUMERAL TRIALS |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 12953490 |
MDR Text Key | 281861724 |
Report Number | 1818910-2021-27387 |
Device Sequence Number | 1 |
Product Code |
HSD
|
UDI-Device Identifier | 10603295004615 |
UDI-Public | 10603295004615 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/07/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/07/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1100-48-610 |
Device Catalogue Number | 110048610 |
Device Lot Number | H29773 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/16/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/10/2017 |
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 |
Treatment | GLBL UNITE ANT BODY 135 SZ 10; GLOBAL UNITE HEAD 48X18 ECC; GLOBAL UNITE STD STEM SZ 10 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 52 YR |
Patient Sex | Female |