Brand Name | R3 20 DEG XLPE ACET LNR 36MM X 54MM |
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
|
0628320660
|
|
MDR Report Key | 6295907 |
MDR Text Key | 66333481 |
Report Number | 1020279-2017-00078 |
Device Sequence Number | 1 |
Product Code |
MBL
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K113848 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
08/09/2017 |
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 | 71335754 |
Device Lot Number | 15HM14296 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/09/2017 |
Initial Date FDA Received | 02/02/2017 |
Supplement Dates Manufacturer Received | Not provided Not provided 04/24/2017
|
Supplement Dates FDA Received | 03/30/2017 04/25/2017 08/09/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/20/2015 |
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 | POLARSTEM FEMORAL STEM, PART&LOT#UNKNOWN; R3 ACETABULAR SHELL, PART&LOT#UNKNOWN; UNKNOWN FEMORAL BALL HEAD, PART&LOT#UNKNOWN |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 72 YR |
Patient Weight | 72 |