Brand Name | FEMORAL IMPLANT IMPACTOR |
Type of Device | PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks rd. |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks rd. |
|
memphis TN 38116 |
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 12415601 |
MDR Text Key | 269821363 |
Report Number | 1020279-2021-06689 |
Device Sequence Number | 1 |
Product Code |
JDG
|
UDI-Device Identifier | 00885556034156 |
UDI-Public | 00885556034156 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123598 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/09/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/02/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 71440005 |
Device Catalogue Number | 71440005 |
Device Lot Number | 17BM17536 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/09/2021 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 09/08/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/22/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|