Brand Name | ACETLR CUP HAP 54MM W/ IMPTR |
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 |
101 hessle road |
|
hull CV31 3HL |
UK
CV31 3HL
|
|
Manufacturer Contact |
claudia
odoy
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
0628320660
|
|
MDR Report Key | 5983057 |
MDR Text Key | 55806450 |
Report Number | 3005975929-2016-00018 |
Device Sequence Number | 1 |
Product Code |
NXT
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | P040033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/27/2016 |
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 | 02/29/2012 |
Device Catalogue Number | 74120154 |
Device Lot Number | 71718 |
Other Device ID Number | 013 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/27/2016
|
Initial Date FDA Received | 09/28/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/15/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/15/2007 |
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 HEAD 46MM #74121146 |
Patient Outcome(s) |
Hospitalization;
|