Brand Name | SUMMIT POR TAPER SZ7 HI OFF |
Type of Device | HIP FEMORAL STEM/SLEEVE |
Manufacturer (Section D) |
DEPUY INTL.,LTD 8010379 |
st. anthony's rd |
leeds LS11 8 DT |
UK LS11 8 DT |
|
Manufacturer (Section G) |
DEPUY INTL.,LTD 8010379 |
st. anthony's rd |
|
leeds LS11 8 DT |
UK
LS11 8 DT
|
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743725905
|
|
MDR Report Key | 5317802 |
MDR Text Key | 34112907 |
Report Number | 1818910-2015-38037 |
Device Sequence Number | 1 |
Product Code |
LPH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK001991 |
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 |
12/07/2015 |
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 Expiration Date | 02/16/2018 |
Device Catalogue Number | 157011135 |
Device Lot Number | CF5GD1000 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/07/2015
|
Initial Date FDA Received | 12/22/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/19/2008 |
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 | 67 YR |
Patient Weight | 90 |