Brand Name | ALPINE |
Type of Device | TOTAL HIP ARTHROPLASTY PROSTHESIS |
Manufacturer (Section D) |
ORTHO DEVELOPMENT |
12187 s. business park drive |
draper UT 84020 |
|
Manufacturer (Section G) |
ORTHO DEVELOPMENT |
12187 s. business park drive |
|
draper UT 84020 |
|
Manufacturer Contact |
drew
weaver
|
12187 s. business park drive |
draper, UT 84020
|
8015539991
|
|
MDR Report Key | 16880322 |
MDR Text Key | 314709920 |
Report Number | 1722511-2023-00013 |
Device Sequence Number | 1 |
Product Code |
KWY
|
UDI-Device Identifier | 00822409000067 |
UDI-Public | (01)00822409000067(17)270802(10)A272613 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K141001 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/13/2023 |
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 Model Number | 700-0014 |
Device Lot Number | A272613 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/13/2023
|
Initial Date FDA Received | 05/05/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/15/2022 |
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 Sex | Female |