Brand Name | R3 0 HOLE ACET SHELL 58MM |
Type of Device | REFLECTION 3 ACETABULAR SYS. |
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 |
robert
rust
|
1450 brooks road |
memphis, TN 38116
|
9013991624
|
|
MDR Report Key | 5438258 |
MDR Text Key | 38238444 |
Report Number | 1020279-2016-00146 |
Device Sequence Number | 1 |
Product Code |
MBL
|
Combination Product (y/n) | N |
Reporter Country Code | FI |
PMA/PMN Number | K070756 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/03/2016 |
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 | 02/28/2019 |
Device Catalogue Number | 71331858 |
Device Lot Number | 09BM00078 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/03/2016 |
Initial Date FDA Received | 02/16/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/19/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/01/2009 |
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 |
Treatment | 74222146/09EW23611 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 66 YR |
Patient Weight | 88 |