Brand Name | ATUNE REV RP TIB BASE SZ 5 CEM |
Type of Device | 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 | 14279981 |
MDR Text Key | 290660822 |
Report Number | 1818910-2022-08122 |
Device Sequence Number | 1 |
Product Code |
NJL
|
UDI-Device Identifier | 10603295042891 |
UDI-Public | 10603295042891 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | P830055 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Study,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/03/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/04/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1506-60-005 |
Device Catalogue Number | 150660005 |
Device Lot Number | 8985686 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/18/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/30/2018 |
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; ATTUNE CEMENTED STEM 14X50MM; ATTUNE CRS FEMORAL RT SZ 5 CEM; ATTUNE DIST FEM AUG SZ 5 12MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE SOLO PINNING SYSTEM; ATTUNE SOLO PINNING SYSTEM; ATUN PRESSFIT STR STEM16X110MM; ATUN TIB SLV M/L 37MM FULL POR; DEPUY CMW 2G 40G |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 62 YR |
Patient Sex | Female |
Patient Weight | 87 KG |