| Brand Name | NOVATION ELEMENT FEMORAL STEM, 12/14, COLLARED, STANDARD OFFSET, HA COATED |
|---|
| Type of Device | FEMORAL STEM |
|---|
| Manufacturer (Section D) |
| EXACTECH, INC. |
| 2320 nw 66th court |
| gainesville 32653 |
|
|---|
| Manufacturer (Section G) |
| EXACTECH, INC. |
| 2320 nw 66th court |
|
| gainesville 32653 |
|
|---|
| Manufacturer Contact |
|
graham
cuthbert
|
| 2320 nw 66th court |
| gainesville 32653
|
|
3523771140
|
|
|---|
| MDR Report Key | 6735257 |
|---|
| MDR Text Key | 80756414 |
|---|
| Report Number | 1038671-2017-00491 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
MEH
|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | US |
|---|
| Number of Events Reported | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
company representative |
|---|
| Reporter Occupation |
Non-Healthcare Professional
|
|---|
| Type of Report
| Initial,Followup |
|---|
| Report Date |
08/27/2018 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Date FDA Received | 07/24/2017 |
|---|
| Is this an Adverse Event Report? |
Yes
|
|---|
| Is this a Product Problem Report? |
No
|
|---|
| Device Operator |
Health Professional
|
|---|
| Device Catalogue Number | 164-03-11 |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Was the Report Sent to FDA? |
No
|
|---|
| Date Manufacturer Received | 07/17/2017 |
|---|
| 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;
|
|
|
