Brand Name | BHR ACETABULAR CUP 54MM |
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 | 7517529 |
MDR Text Key | 108352673 |
Report Number | 3005975929-2018-00164 |
Device Sequence Number | 1 |
Product Code |
NXT
|
UDI-Device Identifier | 03596010502582 |
UDI-Public | 03596010502582 |
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,foreig |
Type of Report
| Initial,Followup |
Report Date |
09/04/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/16/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 74120154 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 05/10/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | FEMORAL STEM, PART # 71312361, LOT # NI; MONOBLOCK HEAD, # 74121346, LOT # NI; FEMORAL STEM, PART # 71312361, LOT # NI; MONOBLOCK HEAD, # 74121346, LOT # NI |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|