Brand Name | ZIMMER CONTINUUM HIGHLY CROSSLINKED POYLETHYLENE LINER |
Type of Device | HIP PROSTHESIS |
Manufacturer (Section D) |
ZIMMER, INC. |
1800 west center street |
warsaw IN 46580 |
|
Manufacturer (Section G) |
ZIMMER, INC. |
1800 west center street |
|
warsaw IN 46580 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 6078851 |
MDR Text Key | 59165527 |
Report Number | 0001822565-2016-04082 |
Device Sequence Number | 1 |
Product Code |
LPH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK151448 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Patient
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/13/2017 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2017 |
Device Catalogue Number | 00875101136 |
Device Lot Number | 62172574 |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/10/2016
|
Initial Date FDA Received | 11/04/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 02/20/2017 04/13/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/09/2012 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Weight | 77 |