FDA Adverse Event
Injury
Summary report: N
SIG MOD TIB TRAY CEM COCR 4
MDR report key: 7554382
·
Received May 30, 2018
Report
- Report Number
- 1818910-2018-60896
- Event Type
- Injury
- Date Received
- May 30, 2018
- Date of Event
- May 3, 2018
- Report Date
- May 3, 2018
- Manufacturer
- DEPUY ORTHOPAEDICS, INC. 1818910
- Product Code
- JWH
- UDI-DI
- 10603295064909
- PMA / PMN Number
- K032151
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO PRODUCT WAS RETURNED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative · 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
THE FOLLOWING IMPLANTS WERE REMOVED TODAY DURING KNEE REVISION SURGERY BY MR (B)(6) HOSPITAL. THE 158124008 LOT D14090146 4 8MM STB TIBIAL INSERT 158140000. LOT 8083182. SIZE 4 COCR TIBIAL TRAY. REASON FOR REVISION WAS ASEPTIC TIBIAL LOOSENING. ORIGINAL SURGERY 2015. THE SURGEON HASN¿T REQUESTED ANY FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396423 | SIG MOD TIB TRAY CEM COCR 4 | SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY | JWH | DEPUY ORTHOPAEDICS, INC. 1818910 | 8083182 | 10603295064909 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |