Brand Name | HIP IMPLANT |
Type of Device | PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
MDR Report Key | 8739440 |
MDR Text Key | 149352107 |
Report Number | 1020279-2019-02480 |
Device Sequence Number | 1 |
Product Code |
JDH
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup |
Report Date |
10/15/2019 |
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
|
Initial Date Manufacturer Received |
06/06/2019
|
Initial Date FDA Received | 06/27/2019 |
Supplement Dates Manufacturer Received | 06/06/2019
|
Supplement Dates FDA Received | 10/15/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|