N
Patient 1
(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INITIAL REPORTER OCCUPATION: LEGAL.
MAUDE MDR 9908044
- MDR report key
- 9908044
- Report number
- 1818910-2020-09813
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-02-06
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. KARA DITTY-BOVARD
- Address
- 700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
- Phone
- 610-610-6107
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SMARTSET MV 40G - EO | BONE CEMENT : BONE CEMENT | DEPUY ORTHOPAEDICS INC US | LOD | 3122-040 | 3122040 | 8751053 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
AFTER REVIEW OF MEDICAL RECORD DATED (B)(6) 2020, IT WAS REPORTED THAT PATIENT SUFFERED FROM ADHESION, PAIN, ALLERGIC REACTION. DOI: (B)(6) 2018, DOR: (B)(6) 2019, RIGHT KNEE.