Brand Name | SIGMA HP TROCHLEA SZ2 RT |
Type of Device | KNEE OTHER IMPLANT |
Manufacturer (Section D) |
1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC |
325 paramount drive |
raynham MA 02767 |
|
Manufacturer (Section G) |
1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC |
325 paramount drive |
|
raynham MA 02767 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743725905
|
|
MDR Report Key | 5337707 |
MDR Text Key | 34735425 |
Report Number | 1818910-2015-38229 |
Device Sequence Number | 1 |
Product Code |
HRY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK061648 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/08/2015 |
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 | 102404200 |
Device Lot Number | 648607 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/08/2015
|
Initial Date FDA Received | 12/31/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/20/2015 |
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 | 38 YR |
|
|