Brand Name | HEMI HEAD 46MM |
Type of Device | PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED |
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 |
claudia
desantis
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
|
MDR Report Key | 6379917 |
MDR Text Key | 69109389 |
Report Number | 3005975929-2017-00044 |
Device Sequence Number | 1 |
Product Code |
KWY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K062408 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
02/12/2018 |
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 | 12/31/2013 |
Device Catalogue Number | 74122546 |
Device Lot Number | 08MW20402 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/20/2017
|
Initial Date FDA Received | 03/06/2017 |
Supplement Dates Manufacturer Received | 02/20/2017 02/20/2017
|
Supplement Dates FDA Received | 07/10/2017 02/12/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/14/2009 |
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 |
Treatment | MODULAR SLEEVE, # 74222200, LOT # 09HW24560 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 83 YR |