Brand Name | DUAL TAPER, SPACER IMPACTOR |
Type of Device | INSTRUMENT, EXTREMITY |
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 | 7328791 |
MDR Text Key | 102211852 |
Report Number | 0001822565-2018-01441 |
Device Sequence Number | 1 |
Product Code |
HSD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK052906 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
08/20/2018 |
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? |
Yes
|
Device Operator |
Physician
|
Device Model Number | N/A |
Device Catalogue Number | 00430903900 |
Device Lot Number | 60902334 |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/21/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/13/2018 |
Initial Date FDA Received | 03/09/2018 |
Supplement Dates Manufacturer Received | 03/12/2018 08/03/2018
|
Supplement Dates FDA Received | 04/05/2018 08/27/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/27/2008 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|