Brand Name | UNKNOWN DEPUY SZ 2.5X12.5 TIBIAL INSERT |
Type of Device | KNEE TIBIAL BEARING/INSERT |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
1818910 DEPUY ORTHOPAEDICS, INC. |
700 orthopaedic drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
steve
dowell
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743714918
|
|
MDR Report Key | 4144831 |
MDR Text Key | 20753903 |
Report Number | 1818910-2014-29472 |
Device Sequence Number | 1 |
Product Code |
HRY
|
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,Distributor,distributor,health prof |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
09/17/2014 |
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 Catalogue Number | UNK-KNEE |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/19/2015
|
Initial Date FDA Received | 10/06/2014 |
Supplement Dates Manufacturer Received | Not provided Not provided Not provided
|
Supplement Dates FDA Received | 11/06/2014 04/13/2015 11/05/2015
|
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 75 YR |
Patient Weight | 78 |