Brand Name | PROFIX {} C/R HA POR FEM SZ 5 LT |
Type of Device | PRSTHSS,KNEE,PATELLO/FMOROTBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COTED,PLYMR/MTL/PLYMR |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
MDR Report Key | 9881262 |
MDR Text Key | 185932983 |
Report Number | 1020279-2020-01017 |
Device Sequence Number | 1 |
Product Code |
MBH
|
UDI-Device Identifier | 03596010484710 |
UDI-Public | 03596010484710 |
Combination Product (y/n) | N |
PMA/PMN Number | K030623 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
07/06/2020 |
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 | 09/07/2014 |
Device Model Number | 71503250 |
Device Catalogue Number | 71503250 |
Device Lot Number | 04GM17371B |
Initial Date Manufacturer Received |
03/05/2020
|
Initial Date FDA Received | 03/25/2020 |
Supplement Dates Manufacturer Received | 06/30/2020
|
Supplement Dates FDA Received | 07/06/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 72 YR |
|
|