Brand Name | FEM HEAD-COCR 40MM/+7 |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED |
Manufacturer (Section D) |
MAKO SURGICAL CORP. |
3365 enterprise ave |
weston FL 33331 |
|
Manufacturer (Section G) |
MAKO SURGICAL CORP. |
3365 enterprise ave |
|
weston FL 33331 |
|
Manufacturer Contact |
arokiya
raj
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 19130536 |
MDR Text Key | 340449256 |
Report Number | 3005985723-2024-00045 |
Device Sequence Number | 1 |
Product Code |
JDI
|
UDI-Device Identifier | 00848486009892 |
UDI-Public | 00848486009892 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K131237 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/17/2024 |
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
|
Device Catalogue Number | 186040-03 |
Device Lot Number | 140073-02 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/25/2024
|
Initial Date FDA Received | 04/18/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 69 YR |
Patient Sex | Male |