Brand Name | BHR ACETABULAR CUP 56MM |
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 | 8614681 |
MDR Text Key | 145208556 |
Report Number | 3005975929-2019-00209 |
Device Sequence Number | 1 |
Product Code |
NXT
|
UDI-Device Identifier | 03596010502599 |
UDI-Public | 03596010502599 |
Combination Product (y/n) | N |
PMA/PMN Number | P040033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
07/09/2019 |
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 Catalogue Number | 74120156 |
Device Lot Number | 16EW12725 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/14/2019
|
Initial Date FDA Received | 05/16/2019 |
Supplement Dates Manufacturer Received | 05/14/2019
|
Supplement Dates FDA Received | 07/09/2019
|
Patient Sequence Number | 1 |
Treatment | FEMORAL HEAD, # 74121150, LOT # 16LW02712; FEMORAL HEAD, # 74121150, LOT # 16LW02712 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|