Brand Name | R3 20 DEG XLPE ACET LNR 32MM X 56MM |
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 |
sarah
freestone
|
101 hessle road |
hull HU3 2-BN
|
UK
HU3 2BN
|
|
MDR Report Key | 7712727 |
MDR Text Key | 114796868 |
Report Number | 1020279-2018-01361 |
Device Sequence Number | 1 |
Product Code |
MBL
|
UDI-Device Identifier | 03596010598516 |
UDI-Public | 03596010598516 |
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 |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
09/07/2018 |
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 |
No Information
|
Device Catalogue Number | 71337656 |
Device Lot Number | 13LM03646 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/27/2018 |
Initial Date FDA Received | 07/23/2018 |
Supplement Dates Manufacturer Received | 06/27/2018
|
Supplement Dates FDA Received | 09/07/2018
|
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 |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|