Brand Name | BHR ACETLR CUP HAP 56MM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
aurora house |
spa park |
leamington spa CV31 3HL |
UK CV31 3HL |
|
Manufacturer (Section G) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
aurora house |
spa park |
leamington spa CV31 3HL |
UK
CV31 3HL
|
|
Manufacturer Contact |
claudia
de santis
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
0628320660
|
|
MDR Report Key | 6224608 |
MDR Text Key | 63912339 |
Report Number | 3005975929-2017-00008 |
Device Sequence Number | 1 |
Product Code |
NXT
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P040033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/14/2016 |
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 |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/14/2016 |
Initial Date FDA Received | 01/05/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/20/2017
|
Was Device Evaluated by Manufacturer? |
No
|
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 | BHR RESURFACING HEAD 48MM PART AND LOT NUMBER NI |
Patient Outcome(s) |
Required Intervention;
|
|
|