Brand Name | ATTUNE CRS RP INSRT SZ 5 20MM |
Type of Device | KNEE TIBIAL INSERT |
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 | 13170583 |
MDR Text Key | 283268969 |
Report Number | 1818910-2022-00232 |
Device Sequence Number | 1 |
Product Code |
NJL
|
UDI-Device Identifier | 10603295055976 |
UDI-Public | 10603295055976 |
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2023 |
Device Model Number | 1517-10-520 |
Device Catalogue Number | 151710520 |
Device Lot Number | 8813980 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/20/2021 |
Initial Date FDA Received | 01/05/2022 |
Supplement Dates Manufacturer Received | 02/02/2022
|
Supplement Dates FDA Received | 02/03/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/06/2018 |
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 DIST FEM AUG SZ 5 4MM.; 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 |