Brand Name | UNK KNEE FEMORAL ATTUNE CR |
Type of Device | FEMORAL |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic drive |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 13117718 |
MDR Text Key | 282960812 |
Report Number | 1818910-2021-29023 |
Device Sequence Number | 1 |
Product Code |
NJL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/30/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNK KNEE FEMORAL ATTUNE CR |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/01/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 14X60 PRESSFIT STEM.; ATTUNE 30 SLEEVE.; ATTUNE 30 SLEEVE.; ATTUNE 5X10 CRS POLY.; ATTUNE 5X10 CRS POLY.; ATUNE PRESSFIT STR STEM14X60MM. |
Patient Outcome(s) |
Required Intervention;
|