Brand Name | R3 ACET SHELL |
Type of Device | HIP IMPLANT |
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 |
connie
mcbroom
|
1450 brooks road |
memphis, TN 38116
|
9013995985
|
|
MDR Report Key | 3832785 |
MDR Text Key | 4405650 |
Report Number | 1020279-2014-00330 |
Device Sequence Number | 1 |
Product Code |
JDH
|
Combination Product (y/n) | N |
Reporter Country Code | SF |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Invalid Data |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/16/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/27/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 05/16/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Required Intervention;
|
Patient Age | 85 YR |
|
|