Brand Name | BHR |
Type of Device | ACETABULAR CUP |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS LTD. |
1 kingmaker court |
warwick technology park |
warwick CV34 6WG |
UK CV34 6WG |
|
Manufacturer (Section G) |
SMITH & NEPHEW |
1 kingmaker court |
warwick technology park |
warwick CV34 6WG |
UK
CV34 6WG
|
|
Manufacturer Contact |
michael
simmonds
|
4419264823
|
|
MDR Report Key | 3580265 |
MDR Text Key | 15266047 |
Report Number | 3005477969-2014-00054 |
Device Sequence Number | 1 |
Product Code |
NXT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P040033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/25/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/17/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/13/2014 |
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 |
Treatment | FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|