Brand Name | ATTUNE MEDIAL DOME PAT 41MM |
Type of Device | ATTUNE IMPLANT : KNEE PATELLA |
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 | 12849996 |
MDR Text Key | 284552477 |
Report Number | 1818910-2021-25783 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 10603295056706 |
UDI-Public | 10603295056706 |
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 |
Study,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/03/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/21/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1518-20-041 |
Device Catalogue Number | 151820041 |
Device Lot Number | 9802736 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/30/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/09/2021 |
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 MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 7 CEM; ATTUNE PS RP INSRT SZ7 6MM; SMARTSET MV ENDURANCE 80G; UNK ATTUNE KNEE TIBIAL TRAY |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 45 YR |
Patient Sex | Male |
Patient Weight | 117 KG |