FDA Adverse Event
Injury
Summary report: N
SIGMA STAB GVF INS 3 15MM
MDR report key: 8159723
·
Received December 13, 2018
Report
- Report Number
- 1818910-2018-78020
- Event Type
- Injury
- Date Received
- December 13, 2018
- Date of Event
- January 3, 2018
- Report Date
- December 11, 2018
- Manufacturer
- JJM (SUZHOU) LTD. 3006356043
- Product Code
- JWH
- UDI-DI
- 10603295064275
- PMA / PMN Number
- K033272
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT #: (B)(4). THE DATE ON THE INITIAL MEDWATCH SHOULD HAVE BEEN 12/11/2018.
Additional Manufacturer Narrative · 1
(B)(4). 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
REVISION DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1001895 | SIGMA STAB GVF INS 3 15MM | SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT | JWH | JJM (SUZHOU) LTD. 3006356043 | D12010664 | 10603295064275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |