Brand Name | GLADIATOR® BIPOLAR 46MM OD X 32MM ID |
Type of Device | HIP COMPONENT |
Manufacturer (Section D) |
MICROPORT ORTHOPEDICS INC. |
5677 airline rd. |
arlington TN 38002 |
|
Manufacturer (Section G) |
MICROPORT ORTHOPEDICS INC. |
5677 airline rd. |
|
arlington TN 38002 |
|
Manufacturer Contact |
|
5677 airline road |
arlington, TN 38002
|
9018674771
|
|
MDR Report Key | 14134838 |
MDR Text Key | 289429827 |
Report Number | 3010536692-2022-00127 |
Device Sequence Number | 1 |
Product Code |
KWY
|
UDI-Device Identifier | M684GLBP32461 |
UDI-Public | M684GLBP32461 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K062693 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
06/09/2022 |
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 |
Other
|
Device Model Number | GLBP3246 |
Device Catalogue Number | GLBP3246 |
Device Lot Number | 1763471 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/29/2022 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 03/22/2022 |
Initial Date Manufacturer Received |
03/22/2022 |
Initial Date FDA Received | 04/18/2022 |
Supplement Dates Manufacturer Received | 03/22/2022
|
Supplement Dates FDA Received | 06/09/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |