Brand Name | ACETLR CUP HAP 58MM W/ IMPTR |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
aurora house |
spa park |
leamington spa CV31 3HL |
UK CV31 3HL |
|
MDR Report Key | 9659601 |
MDR Text Key | 177401967 |
Report Number | 3005975929-2020-00036 |
Device Sequence Number | 1 |
Product Code |
NXT
|
UDI-Device Identifier | 03596010502605 |
UDI-Public | 03596010502605 |
Combination Product (y/n) | N |
PMA/PMN Number | P040033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Type of Report
| Initial,Followup |
Report Date |
02/04/2020 |
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 |
Lay User/Patient
|
Device Expiration Date | 08/03/2010 |
Device Model Number | 74120158 |
Device Catalogue Number | 74120158 |
Device Lot Number | 52604 |
Initial Date Manufacturer Received |
01/20/2020 |
Initial Date FDA Received | 02/03/2020 |
Supplement Dates Manufacturer Received | 02/03/2020
|
Supplement Dates FDA Received | 02/04/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|