Brand Name | BHR ACETABULAR CUP HAP 44MM W/ IMPTR |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
1 kingmaker court |
gallows hill CV34 6WG |
UK CV34 6WG |
|
Manufacturer (Section G) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
aurora, spa park |
harrison way |
leamington spa CV31 3HL |
UK
CV31 3HL
|
|
Manufacturer Contact |
terry
mcmahon
|
970 lake carillon dr |
st petersburg, FL 33716
|
0628320660
|
|
MDR Report Key | 4873824 |
MDR Text Key | 6058604 |
Report Number | 3005477969-2015-00185 |
Device Sequence Number | 1 |
Product Code |
NXT
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | P040033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,consumer |
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
06/23/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/29/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 08/30/2013 |
Device Model Number | 74122152 |
Device Catalogue Number | 74122152 |
Device Lot Number | 08HW18303 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/26/2015 |
Date Device Manufactured | 08/31/2008 |
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 | 61 YR |
Patient Weight | 60 |
|
|