Brand Name | BIPOLAR LINER |
Type of Device | PROSTHESIS, HIP |
Manufacturer (Section D) |
ZIMMER MANUFACTURING B.V. |
turpeaux industrial park |
route #1 km 123.4 bldg #1 |
mercedita PR 00715 |
|
Manufacturer (Section G) |
ZIMMER MANUFACTURING B.V. |
turpeaux industrial park |
route #1 km 123.4 bldg #1 |
mercedita PR 00715 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 6181167 |
MDR Text Key | 62597584 |
Report Number | 0002648920-2016-04390 |
Device Sequence Number | 1 |
Product Code |
KWY
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | PK833991 |
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 |
11/20/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/16/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2021 |
Device Model Number | N/A |
Device Catalogue Number | 00500104728 |
Device Lot Number | 62402101 |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/17/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/21/2013 |
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|