Brand Name | R3 MULTI HOLE ACETABULAR SHELL 50MM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMR, 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
|
1450 brooks road |
memphis, TN 38116
|
0447940038
|
|
MDR Report Key | 9828575 |
MDR Text Key | 183250175 |
Report Number | 1020279-2020-00858 |
Device Sequence Number | 1 |
Product Code |
MBL
|
UDI-Device Identifier | 00885556020630 |
UDI-Public | 00885556020630 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K092386 |
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 |
12/17/2020 |
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 Model Number | 71338664 |
Device Catalogue Number | 71338664 |
Device Lot Number | 19JW12669 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/27/2020 |
Initial Date FDA Received | 03/13/2020 |
Supplement Dates Manufacturer Received | 12/13/2020
|
Supplement Dates FDA Received | 12/17/2020
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/27/2020 |
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|