Brand Name | M/L TAPER FEMORAL PRESS-FIT STEM EXTENDED OFFSET |
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 |
carrie
schneider
|
p.o. box 708 |
warsaw, IN 46581-0708
|
8006136131
|
|
MDR Report Key | 5911380 |
MDR Text Key | 53395674 |
Report Number | 0001822565-2016-02956 |
Device Sequence Number | 1 |
Product Code |
LZO
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | PK042337 |
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 |
08/01/2016 |
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 Catalogue Number | 65771100720 |
Device Lot Number | 63102994 |
Other Device ID Number | SEE H10 NARRATIVE |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/01/2016
|
Initial Date FDA Received | 08/29/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 02/14/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/31/2015 |
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 |
|
|