Brand Name | REFLECTION INTERFIT ACET SHELL THREE HOLE SZ 48MM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks road |
|
memphis TN 38116 |
|
Manufacturer Contact |
claudia
de santis
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
9013995009
|
|
MDR Report Key | 6316207 |
MDR Text Key | 67082121 |
Report Number | 1020279-2017-00095 |
Device Sequence Number | 1 |
Product Code |
MBL
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K960094 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
08/28/2017 |
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 Catalogue Number | 71336048 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/04/2017 |
Initial Date FDA Received | 02/09/2017 |
Supplement Dates Manufacturer Received | 02/04/2017
|
Supplement Dates FDA Received | 08/28/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 71333313, REFLECTION XLPE 26ID 20 DEGREE 46-48 OD |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|