Brand Name | ATUNE CRS FB TIB BASE SZ 6 CEM |
Type of Device | ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
|
cork |
EI
|
|
Manufacturer Contact |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 14655644 |
MDR Text Key | 293732782 |
Report Number | 1818910-2022-10655 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 10603295042808 |
UDI-Public | 10603295042808 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K160700 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Study,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/10/2022 |
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 |
Health Professional
|
Device Model Number | 1506-40-006 |
Device Catalogue Number | 150640006 |
Device Lot Number | 9652842 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/01/2022 |
Initial Date FDA Received | 06/10/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/09/2020 |
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 |
Treatment | ATTUN REV OFFST STM ADPTR 4MM; ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FB INSRT SZ 7 16MM; ATTUNE CRS FEMORAL RT SZ 7 CEM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 7 8MM; ATTUNE POS FEM AUG SZ 7 8MM; ATUN PRESSFIT STR STEM24X110MM; ATUNE CRS FB TIB BASE SZ 6 CEM; ATUNE PRESSFIT STR STEM22X60MM; COMPETITOR CEMENT MANUFACTURER (STRYKER); COMPETITOR CEMENT MANUFACTURER (STRYKER) |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 71 YR |
Patient Sex | Female |
Patient Weight | 89 KG |
Patient Ethnicity | Non Hispanic |