Brand Name | PRSVN ALLPOLY TIB LMRL S2 7MM |
Type of Device | KNEE TIBIAL BEARING/INSERT |
Manufacturer (Section D) |
DEPUY INTERNATIONAL LTD. 8010379 |
st. anthony's rd |
leeds, leeds LS11 8 DT |
UK LS11 8 DT |
|
Manufacturer (Section G) |
DEPUY INTERNATIONAL LTD. 8010379 |
st. anthony's rd |
|
leeds, leeds LS11 8 DT |
UK
LS11 8 DT
|
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743725905
|
|
MDR Report Key | 5608711 |
MDR Text Key | 43661016 |
Report Number | 1818910-2016-18094 |
Device Sequence Number | 1 |
Product Code |
HRY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK010810 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/14/2016 |
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 Expiration Date | 08/06/2011 |
Device Catalogue Number | 149812206 |
Device Lot Number | YAL-18 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/14/2016
|
Initial Date FDA Received | 04/26/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/23/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/08/2001 |
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 | 78 YR |