Brand Name | ARTICULAR SURFACE PROVISIONAL SIZE E 14 MM HEIGHT |
Type of Device | INSTRUMENT, KNEE |
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 | 11033929 |
MDR Text Key | 222282250 |
Report Number | 0001822565-2020-04158 |
Device Sequence Number | 1 |
Product Code |
HWT
|
UDI-Device Identifier | 00889024200197 |
UDI-Public | (01)00889024200197(10)63354161 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/17/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 00588105014 |
Device Lot Number | 63354161 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/10/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/07/2020 |
Initial Date FDA Received | 12/17/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/10/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |