Brand Name | HIP COMPONENTS |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED |
Manufacturer (Section D) |
EXACTECH, INC. |
2320 nw 66 court |
gainesville FL 32653 |
|
Manufacturer (Section G) |
EXACTECH, INC. |
2320 nw 66th ct |
|
gainesville FL |
|
Manufacturer Contact |
matt
collins
|
2320 nw 66th ct |
gainesville, FL 32653
|
3523771140
|
|
MDR Report Key | 19155130 |
MDR Text Key | 340795887 |
Report Number | 1038671-2024-00933 |
Device Sequence Number | 1 |
Product Code |
JDI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/22/2024 |
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
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/27/2024 |
Initial Date FDA Received | 04/22/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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) |
Required Intervention;
|
|
|