Brand Name | BHR |
Type of Device | ACETABULAR CUP |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
aurora house |
spa park |
leamington spa CV31 3HL |
UK CV31 3HL |
|
Manufacturer (Section G) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
aurora house |
spa park |
leamington spa CV31 3HL |
UK
CV31 3HL
|
|
Manufacturer Contact |
terry
mcmahon
|
970 lake carillon drive |
st petersburg, FL 33716
|
4419264823
|
|
MDR Report Key | 4619607 |
MDR Text Key | 21244767 |
Report Number | 3005477969-2015-00087 |
Device Sequence Number | 1 |
Product Code |
NXT
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | P040033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,company representati |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/20/2015 |
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 | 12/31/2012 |
Device Catalogue Number | 74120156 |
Device Lot Number | 081838 008 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/07/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/18/2015 |
Initial Date FDA Received | 03/20/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 10/29/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/02/2008 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 64 YR |