Brand Name | ZUK PRECOAT FEMORAL COMPONENT HIGH-FLEX |
Manufacturer (Section D) |
ZIMMER INC |
p.o. box 708 |
warsaw IN 46581 070 |
|
Manufacturer Contact |
kevin
escapule
|
p.o. box 708 |
warsaw, IN 46581-0708
|
8006136131
|
|
MDR Report Key | 3692555 |
MDR Text Key | 4304327 |
Report Number | 1822565-2014-00333 |
Device Sequence Number | 1 |
Product Code |
HSX
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/11/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/13/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2014 |
Device Catalogue Number | 00584201602 |
Device Lot Number | 60158236 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/11/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/01/2004 |
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 | CATALOG #00584200402, LOT #60352934; ZUK PRECOAT TIBIAL COMPONENT, |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 65 YR |
Patient Weight | 108 |
|
|