Brand Name | 32MM MOD HEAD COCR -3MM NECK |
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 | 14013569 |
MDR Text Key | 288591468 |
Report Number | 0001825034-2022-00800 |
Device Sequence Number | 1 |
Product Code |
JDG
|
UDI-Device Identifier | 00887868308321 |
UDI-Public | (01)00887868308321(17)160107(10)00J3698303 |
Combination Product (y/n) | N |
Reporter Country Code | DA |
PMA/PMN Number | K942479 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Literature,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/04/2022 |
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 Model Number | N/A |
Device Catalogue Number | 163668 |
Device Lot Number | 00J3698303 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/31/2022 |
Initial Date FDA Received | 04/05/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/07/2016 |
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 | CAT# 010000664 LOT# 3659134 G7 SHELL; CAT# 010000850 LOT# 3697412 G7 LINER |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 71 YR |
Patient Sex | Female |