Brand Name | UNKNOWN INSALL/BURSTEIN KNEE IMPLANT |
Type of Device | KNEE PROSTHESIS |
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 | 4709905 |
MDR Text Key | 5722623 |
Report Number | 1822565-2015-00562 |
Device Sequence Number | 1 |
Product Code |
HSA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Literature,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/17/2015 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/17/2015 |
Initial Date FDA Received | 04/17/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
|
|