Brand Name | R3 20 DEG +4 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 |
|
MDR Report Key | 8130578 |
MDR Text Key | 129248472 |
Report Number | 1020279-2018-02677 |
Device Sequence Number | 1 |
Product Code |
MBL
|
Combination Product (y/n) | N |
PMA/PMN Number | K113848 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup |
Report Date |
04/22/2019 |
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 | 71338554 |
Device Lot Number | 16CM19011 |
Initial Date Manufacturer Received |
11/09/2018 |
Initial Date FDA Received | 12/04/2018 |
Supplement Dates Manufacturer Received | 11/09/2018 11/09/2018
|
Supplement Dates FDA Received | 04/12/2019 04/22/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|