Brand Name | SROM STM ST,36+6L NK,11X16X150 |
Type of Device | HIP FEMORAL STEM/SLEEVE |
Manufacturer (Section D) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
|
cork |
EI
|
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743725905
|
|
MDR Report Key | 6587141 |
MDR Text Key | 75852314 |
Report Number | 1818910-2017-18587 |
Device Sequence Number | 1 |
Product Code |
MRA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P070026 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/26/2017 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 563517 |
Device Lot Number | 8072989 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/26/2017 |
Initial Date FDA Received | 05/24/2017 |
Supplement Dates Manufacturer Received | 10/06/2017
|
Supplement Dates FDA Received | 10/07/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/25/2015 |
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 Weight | 120 |
|
|