FDA Adverse Event
Injury
Summary report: N
MBT CEM KEEL TIB TRAY SZ2
MDR report key: 9412144
·
Received December 4, 2019
Report
- Report Number
- 1818910-2019-120263
- Event Type
- Injury
- Date Received
- December 4, 2019
- Date of Event
- November 11, 2019
- Report Date
- November 11, 2019
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- NJL
- UDI-DI
- 10603295025764
- PMA / PMN Number
- P830055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PRODUCT COMPLAINT # : (B)(4). THIS IS A DUPLICATE REPORT OF (MFR NO.) 1818910-2019-120379. 1818910-2019-120263 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2019-120379 WILL BE KEPT FOR INVESTIGATIONAL PURPOSES.
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
Description of Event or Problem · 1
THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. PREVIOUS SURGERY DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1207342 | MBT CEM KEEL TIB TRAY SZ2 | MBT TIBIAL TRAY : KNEE TIBIAL TRAY | NJL | DEPUY ORTHOPAEDICS INC US | 2456796 | 10603295025764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |