Brand Name | CONTINUUM, TRILOGY IT, ALLOFIT IT LINER |
Type of Device | HIP PROSTHESIS |
Manufacturer (Section D) |
ZIMMER, INC. |
1800 west center street |
warsaw IN 46580 |
|
Manufacturer (Section G) |
ZIMMER, INC. |
1800 west center street |
|
warsaw IN 46580 |
|
Manufacturer Contact |
carrie
schneider
|
p.o. box 708 |
warsaw, IN 46581-0708
|
8006136131
|
|
MDR Report Key | 5689206 |
MDR Text Key | 46223969 |
Report Number | 0001822565-2016-01852 |
Device Sequence Number | 1 |
Product Code |
LZO
|
Combination Product (y/n) | N |
PMA/PMN Number | PN/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/03/2016 |
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
|
Device Expiration Date | 03/31/2020 |
Device Catalogue Number | 00875101336 |
Device Lot Number | 62980584 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/03/2016 |
Initial Date FDA Received | 05/31/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 11/02/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/23/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 81 YR |
Patient Weight | 118 |
|
|