Brand Name | ACETLR CUP HAP 52MM 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 |
|
Manufacturer (Section G) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
aurora house |
spa park |
leamington spa CV31 3HL |
UK
CV31 3HL
|
|
Manufacturer Contact |
markus
poettker
|
schachenallee 29 |
aarau 05001
|
SZ
05001
|
|
MDR Report Key | 7154499 |
MDR Text Key | 96044995 |
Report Number | 3005975929-2017-00477 |
Device Sequence Number | 1 |
Product Code |
NXT
|
UDI-Device Identifier | 03596010502575 |
UDI-Public | 03596010502575 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P040033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/23/2018 |
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 |
Health Professional
|
Device Expiration Date | 03/31/2014 |
Device Catalogue Number | 74120152 |
Device Lot Number | 099120 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/16/2017 |
Initial Date FDA Received | 12/29/2017 |
Supplement Dates Manufacturer Received | 10/16/2017
|
Supplement Dates FDA Received | 04/23/2018
|
Date Device Manufactured | 03/26/2009 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 52 YR |
|
|