Brand Name | ATTUNE MEDIAL DOME PAT 35MM |
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 | 13307597 |
MDR Text Key | 284123015 |
Report Number | 1818910-2022-01249 |
Device Sequence Number | 1 |
Product Code |
NJL
|
UDI-Device Identifier | 10603295056683 |
UDI-Public | 10603295056683 |
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 |
01/20/2022 |
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 | 1518-20-035 |
Device Catalogue Number | 151820035 |
Device Lot Number | 9852144 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/10/2022 |
Initial Date FDA Received | 01/20/2022 |
Supplement Dates Manufacturer Received | 02/01/2022
|
Supplement Dates FDA Received | 02/02/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/26/2021 |
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 CR FEM RT SZ 4 CEM; ATTUNE CR RP INSRT SZ 4 6MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE RP TIB BASE SZ 3 CEM |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 61 YR |
Patient Sex | Female |
Patient Weight | 54 KG |