Brand Name | R3 MULTI HOLE ACETABULAR SHELL 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 |
sarah
freestone
|
1450 brooks road |
memphis, TN 38116
|
0447940038
|
|
MDR Report Key | 9820851 |
MDR Text Key | 183303819 |
Report Number | 1020279-2020-00834 |
Device Sequence Number | 1 |
Product Code |
MBL
|
UDI-Device Identifier | 00885556021804 |
UDI-Public | 00885556021804 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K092386 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup,Followup,Followup |
Report Date |
09/28/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 71338666 |
Device Catalogue Number | 71338666 |
Device Lot Number | 18HM03836 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/16/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/03/2019 |
Initial Date FDA Received | 03/11/2020 |
Supplement Dates Manufacturer Received | 01/03/2019 01/03/2019 12/06/2021 12/06/2021 09/27/2022
|
Supplement Dates FDA Received | 03/11/2020 04/14/2020 12/05/2021 12/06/2021 09/29/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/08/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-2331-2020 |
Patient Sequence Number | 1 |
Treatment | 71332754 / 18FM16740 |