Brand Name | ATTUNE DIST FEM AUG SZ 5 4MM |
Type of Device | KNEE FEMORAL ACCESSORY |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY IRELAND - 9616671 |
loughbeg, ringaskiddy co |
|
cork |
EI
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 13170746 |
MDR Text Key | 283769496 |
Report Number | 1818910-2022-00247 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 10603295382744 |
UDI-Public | 10603295382744 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P830055 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/05/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/05/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1547-05-001 |
Device Catalogue Number | 154705001 |
Device Lot Number | J02K76 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/02/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/09/2018 |
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 | ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL RT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 20MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE POS FEM AUG SZ 5 8MM; ATTUNE POS FEM AUG SZ 5 8MM; ATTUNE SOLO PINNING SYSTEM; ATUN PRESSFIT STR STEM12X110MM; ATUN TIB AUG LM/RL SZ 5/6 10MM; ATUN TIB AUG RM/LL SZ 5/6 10MM; ATUN TIB SLV M/L 29MM FULL POR; ATUNE REV RP TIB BASE SZ 5 CEM; CEMENT RESTRICTOR SIZE 4; UNK CEMENT SMARTSET MV |
Patient Outcome(s) |
Required Intervention;
Required Intervention;
|
Patient Age | 78 YR |
Patient Sex | Male |