Brand Name | ANTHOLOGY INSERTER POSTER HARD |
Type of Device | PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
MDR Report Key | 9168987 |
MDR Text Key | 161739160 |
Report Number | 1020279-2019-03590 |
Device Sequence Number | 1 |
Product Code |
MEH
|
Combination Product (y/n) | N |
PMA/PMN Number | K113789 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
10/31/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 71365705 |
Device Lot Number | 18HM08532 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/26/2019 |
Initial Date Manufacturer Received |
09/12/2019 |
Initial Date FDA Received | 10/08/2019 |
Supplement Dates Manufacturer Received | 09/12/2019
|
Supplement Dates FDA Received | 10/31/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|