Brand Name | SIGMA HP UNI FEMORAL SZ2 LM/RL |
Type of Device | EARLY INTERVENTION : KNEE FEMORAL |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
MDR Report Key | 10754729 |
MDR Text Key | 213642200 |
Report Number | 1818910-2020-23524 |
Device Sequence Number | 1 |
Product Code |
NPJ
|
UDI-Device Identifier | 10603295001720 |
UDI-Public | 10603295001720 |
Combination Product (y/n) | N |
PMA/PMN Number | K070849 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup,Followup |
Report Date |
10/13/2020 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 1024-07-200 |
Device Catalogue Number | 102407200 |
Device Lot Number | HH4615 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/13/2020
|
Initial Date FDA Received | 10/29/2020 |
Supplement Dates Manufacturer Received | 11/15/2020 12/03/2020
|
Supplement Dates FDA Received | 11/26/2020 12/04/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | SIGMA HP UNI FEMORAL SZ2 LM/RL.; SIGMA HP UNI INS SZ2 7MM LM/RL.; SIGMA HP UNI INS SZ2 7MM LM/RL.; SIGMA HP UNI TIB TRAY SZ2 LMRL.; SIGMA HP UNI TIB TRAY SZ2 LMRL.; SMARTSET HV BONE CEMENT 40G.; UNK CEMENT SMARTSET.; SIGMA HP UNI FEMORAL SZ2 LM/RL; SIGMA HP UNI INS SZ2 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ2 LMRL; UNK CEMENT SMARTSET |
Patient Outcome(s) |
Required Intervention;
|