Brand Name | ATTUNE DIST FEM AUG SZ 5 12MM |
Type of Device | KNEE FEMORAL ACCESSORY |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655 |
325 paramount drive |
|
raynham MA 02767 |
|
Manufacturer Contact |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 14280114 |
MDR Text Key | 290665160 |
Report Number | 1818910-2022-08126 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 10603295382768 |
UDI-Public | 10603295382768 |
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 |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1547-05-003 |
Device Catalogue Number | 154705003 |
Device Lot Number | HJ7371 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/22/2022 |
Initial Date FDA Received | 05/04/2022 |
Supplement Dates Manufacturer Received | 05/18/2022
|
Supplement Dates FDA Received | 05/19/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/06/2017 |
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 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; ATUNE REV RP TIB BASE SZ 5 CEM; DEPUY CMW 2G 40G |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 62 YR |
Patient Sex | Female |
Patient Weight | 87 KG |