Brand Name | NUT COMPRESSION CEMENTLESS |
Type of Device | PROSTHESIS, HIP |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 7769130 |
MDR Text Key | 116631337 |
Report Number | 0001822565-2018-03680 |
Device Sequence Number | 1 |
Product Code |
LWJ
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | PK992667 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
09/05/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2021 |
Device Model Number | N/A |
Device Catalogue Number | 00998209902 |
Device Lot Number | 61880566 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/15/2018
|
Initial Date FDA Received | 08/09/2018 |
Supplement Dates Manufacturer Received | 08/17/2018
|
Supplement Dates FDA Received | 09/11/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/19/2011 |
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 |
Treatment | 00998201718 FEMORAL STEM, LOT 62398928; 00999101845 FEMORAL BODY, LOT 6231801 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|