Brand Name | JOURNEY PF IMPLANT MED LT |
Type of Device | PATELLO-FEMORAL REPLACEMENT |
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 | 5029422 |
MDR Text Key | 24010902 |
Report Number | 1020279-2015-00603 |
Device Sequence Number | 1 |
Product Code |
KRR
|
Combination Product (y/n) | N |
Reporter Country Code | SF |
PMA/PMN Number | K051086 |
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
| Followup |
Report Date |
08/12/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/25/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/18/2019 |
Device Catalogue Number | 71461014 |
Device Lot Number | 09EM14423 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/12/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/20/2009 |
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 | 63 YR |