FDA Adverse Event
Injury
Summary report: N
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM
MDR report key: 8277364
·
Received January 25, 2019
Report
- Report Number
- 3005180920-2019-00008
- Event Type
- Injury
- Date Received
- January 25, 2019
- Date of Event
- December 28, 2018
- Report Date
- January 25, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030817991
- PMA / PMN Number
- K103170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 22 JANUARY 2019. LOT 180469: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MAY 2018 . EXPIRATION DATE: 2023-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SUBLUXED TIBIA 10 DAYS AFTER PRIMARY. THE SURGEON DETERMINED THAT A POLY SWAP WAS NEEDED DUE TO THE SUBLUXED TIBIA. IT IS UNCLEAR AT THIS TIME WHAT CAUSED THE SUBLUXED TIBIA. THE 17 SC POLY WAS REMOVED AND REPLACED WITH A 26 SC POLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71761 | GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM | FIXED TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 180469 | 07630030817991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |