| 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;
|
|
|
