Brand Name | ZUK PRECOAL TIBIAL COMPONENT |
Type of Device | HSX |
Manufacturer (Section D) |
ZIMMER, INC. |
po box |
warsaw IN 46581 070 |
|
Manufacturer Contact |
kevin
escapule
|
po box 708 |
warsaw, IN 46581-0708
|
8006136131
|
|
MDR Report Key | 4112596 |
MDR Text Key | 21805622 |
Report Number | 1822565-2014-01096 |
Device Sequence Number | 1 |
Product Code |
HSX
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/12/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/10/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/29/2024 |
Device Catalogue Number | 00584200302 |
Device Lot Number | 62600870 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 09/08/2014 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 08/12/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/01/2014 |
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 |
|
|