Brand Name | NEXGEN LPS-FLEX FEMORAL COMPONENT |
Type of Device | NJL |
Manufacturer (Section D) |
ZIMMER, BUILDING #2 |
east park, shannon industrial |
estate,shannon, co. clare, |
|
EI |
|
Manufacturer (Section G) |
ZIMMER, BUILDING #2 |
east park, shannon industrial |
estate,shannon, co. clare, |
|
EI
|
|
Manufacturer Contact |
kevin
escapule
|
p.o. box 708 |
warsaw, IN 46581-0708
|
8006136131
|
|
MDR Report Key | 5572622 |
MDR Text Key | 42979467 |
Report Number | 3007963827-2016-00028 |
Device Sequence Number | 1 |
Product Code |
NJL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
01/02/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/12/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2022 |
Device Catalogue Number | 00596401652 |
Device Lot Number | 62154995 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/08/2014 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/02/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/18/2012 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-0845-2016 |
Patient Sequence Number | 1 |
|
|