Brand Name | TPRLC XR T1 PPS 16X152MM |
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 | 9856717 |
MDR Text Key | 185081568 |
Report Number | 0001825034-2020-01173 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 00880304517172 |
UDI-Public | (01)00880304517172 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K120030 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/19/2020 |
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 Expiration Date | 11/30/2022 |
Device Model Number | N/A |
Device Catalogue Number | 51-105160 |
Device Lot Number | 2867469 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/17/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/26/2020
|
Initial Date FDA Received | 03/19/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/08/2012 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | NI |
Patient Sequence Number | 1 |
|
|