Brand Name | ATTUNE PS FB INSRT SZ 5 6MM |
Type of Device | ATTUNE IMPLANT : KNEE TIBIAL INSERT |
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 |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 12860512 |
MDR Text Key | 281139692 |
Report Number | 1818910-2021-26123 |
Device Sequence Number | 1 |
Product Code |
OIY
|
UDI-Device Identifier | 10603295049937 |
UDI-Public | 10603295049937 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K111433 |
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 |
11/09/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/23/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1516-40-506 |
Device Catalogue Number | 151640506 |
Device Lot Number | J4842R |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/02/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/07/2019 |
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 ANAT PAT 32MM; ATTUNE PS FB INSRT SZ 5 6MM; ATTUNE PS FEM RT SZ 5 NAR CEM; ATUNE CRS FB TIB BASE SZ 3 CEM; SMARTSET MV 40G - EO |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 55 YR |
Patient Weight | 92 KG |