Brand Name | UNKNOWN DEPUY SROM FEMORAL STEM |
Type of Device | HIP FEMORAL HEAD |
Manufacturer (Section D) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
cork, munster IN 46582 |
EI 46582 |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
|
cork IN 46582 |
EI
46582
|
|
Manufacturer Contact |
stacey
trick
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743714554
|
|
MDR Report Key | 3588969 |
MDR Text Key | 4185971 |
Report Number | 1818910-2014-11466 |
Device Sequence Number | 1 |
Product Code |
KXA
|
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,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/14/2014 |
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 | UNK-HIP |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/13/2014
|
Initial Date FDA Received | 01/23/2014 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/13/2014
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 43 YR |
|
|