Brand Name | MOVATION KNEE |
Type of Device | MOVATION TIBIAL INSERT, SIZE 8, 9MM VE |
Manufacturer (Section D) |
ENCORE MEDICAL, L.P. |
9800 metric blvd. |
austin TX 78758 |
|
Manufacturer (Section G) |
ENCORE MEDICAL L.P. |
9800 metric blvd. |
|
austin TX 78758 5445 |
|
Manufacturer Contact |
teffany
hutto
|
9800 metric blvd. |
austin, TX 78758-5445
|
|
MDR Report Key | 6437095 |
MDR Text Key | 70973960 |
Report Number | 1644408-2017-00190 |
Device Sequence Number | 1 |
Product Code |
OIY
|
UDI-Device Identifier | 00888912112437 |
UDI-Public | (01)00888912112437 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K121727 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/05/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/27/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2019 |
Device Model Number | 292-09-708 |
Device Catalogue Number | 292-09-708 |
Device Lot Number | 328N1004 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/06/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/02/2014 |
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) |
Required Intervention;
|
Patient Age | 55 YR |
|
|