Brand Name | R3 ACETABULAR LINER 50MM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL |
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
odoy
|
schachenallee 29 |
aarau, FL
|
SZ
|
|
MDR Report Key | 5073716 |
MDR Text Key | 25613645 |
Report Number | 3005477969-2015-00255 |
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 |
health professional |
Reporter Occupation |
Physician
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
09/02/2015 |
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 Catalogue Number | 71341150 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/04/2015
|
Initial Date FDA Received | 09/14/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/11/2016
|
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 Age | 71 YR |
Patient Weight | 58 |
|
|