Brand Name | JOURNEY UNI TIB BASE RM/LL SZ 5 |
Type of Device | KNEE PROSTHESIS |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks road |
|
memphis TN 38116 |
|
Manufacturer Contact |
robert
rust
|
1450 brooks road |
memphis, TN 38116
|
9013991624
|
|
MDR Report Key | 5246608 |
MDR Text Key | 32031718 |
Report Number | 1020279-2015-00808 |
Device Sequence Number | 1 |
Product Code |
HSX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K061011 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/29/2015 |
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 | 04/07/2019 |
Device Catalogue Number | 71422235 |
Device Lot Number | 09DM07604 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/23/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/29/2015 |
Initial Date FDA Received | 11/24/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/13/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/09/2009 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-0933-2010 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 59 YR |
Patient Weight | 97 |