FDA Adverse Event
Injury
Summary report: N
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/14MM
MDR report key: 16813630
·
Received April 26, 2023
Report
- Report Number
- 3005180920-2023-00298
- Event Type
- Injury
- Date Received
- April 26, 2023
- Date of Event
- April 3, 2023
- Report Date
- April 26, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030816710
- PMA / PMN Number
- K103170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 04 APRIL 2023: LOT 2003156: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JULY-2020. EXPIRATION DATE: 2025-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. AT ABOUT 3 WEEKS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 791522 | GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/14MM | KNEE TIBIAL INSERT SC | JWH | MEDACTA INTERNATIONAL SA | 02.07.0214SCF | 2003156 | 07630030816710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |