Brand Name | CONTOURED ARTICULAR PROSTHETIC (CAP) FEMORAL HEAD RESURFACING SYSTEM |
Type of Device | PROSTHESIS, HIP, HEMI-, RESURFACING, METALLIC |
Manufacturer (Section D) |
ARTHROSURFACE, INC. |
28 forge parkway |
franklin MA 02038 |
|
Manufacturer (Section G) |
PRIMO MEDICAL GROUP |
75 mill st. |
|
stoughton MA 02072 |
|
Manufacturer Contact |
phani
puppala
|
28 forge parkway |
franklin, MA 02038
|
5085203003
|
|
MDR Report Key | 5619555 |
MDR Text Key | 44222433 |
Report Number | 3004154314-2016-00011 |
Device Sequence Number | 1 |
Product Code |
KXA
|
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | K021549 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
04/01/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/29/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Catalogue Number | H359-3060 |
Device Lot Number | 75DF1428 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/26/2016 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 04/01/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/19/2006 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|