FDA Adverse Event
Injury
Summary report: N
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/14MM
MDR report key: 15494323
·
Received September 27, 2022
Report
- Report Number
- 3005180920-2022-00728
- Event Type
- Injury
- Date Received
- September 27, 2022
- Date of Event
- August 30, 2022
- Report Date
- September 27, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030818455
- PMA / PMN Number
- K103170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 06-SEP-2022. LOT 2110101: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2021. EXPIRATION DATE: 2026-09-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
PATIENT WAS REVISED FROM COMPETITOR COMPONENTS TO MEDACTA ON (B)(6) 2022. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1905420 | GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/14MM | FIXED TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.07.0514SCF | 2110101 | 07630030818455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |