Brand Name | BOWED CONICAL STEM 15 X 195MM RESTORATION MODULAR HIP SYSTEM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
Manufacturer (Section D) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
mahwah NJ 07430 |
|
Manufacturer (Section G) |
STRYKER ORTHOPAEDICS-CORK |
ida industrial estate |
|
carrigtwohill NA |
|
Manufacturer Contact |
keyla
colon
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 5563430 |
MDR Text Key | 42319207 |
Report Number | 0002249697-2016-01131 |
Device Sequence Number | 1 |
Product Code |
LPH
|
Combination Product (y/n) | N |
Reporter Country Code | SE |
PMA/PMN Number | K121308 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/14/2016 |
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 Expiration Date | 03/30/2018 |
Device Catalogue Number | 6276-7-215 |
Device Lot Number | CAXNA39E |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/16/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/14/2016 |
Initial Date FDA Received | 04/08/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 07/05/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/27/2013 |
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) |
Hospitalization;
Required Intervention;
|
Patient Weight | 96 |