Brand Name | R3 ACETABULAR LINER 56MM |
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 5001
|
SZ
5001
|
|
MDR Report Key | 5229066 |
MDR Text Key | 31357207 |
Report Number | 3005477969-2015-00297 |
Device Sequence Number | 1 |
Product Code |
NXT
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | P040033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/27/2015 |
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 Expiration Date | 09/30/2018 |
Device Catalogue Number | 71335856 |
Device Lot Number | 08JW18763 053 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/12/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/27/2015
|
Initial Date FDA Received | 11/17/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/11/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/30/2008 |
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 | MODULAR SLEEVE, # 74222200, LOT # 09BW222200 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 66 YR |