FDA Adverse Event
Injury
Summary report: N
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM
MDR report key: 17378590
·
Received July 24, 2023
Report
- Report Number
- 3005180920-2023-00570
- Event Type
- Injury
- Date Received
- July 24, 2023
- Date of Event
- June 29, 2023
- Report Date
- July 24, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030817878
- PMA / PMN Number
- K103170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 03 JULY 2023. LOT 2111869: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JULY-2021. EXPIRATION DATE: 2026-OCT-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ONE MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 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 |
|---|---|---|---|---|---|---|---|
| 1271733 | GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2111869 | 07630030817878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |