FDA Adverse Event
Injury
Summary report: N
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM
MDR report key: 19210982
·
Received April 30, 2024
Report
- Report Number
- 3005180920-2024-00269
- Event Type
- Injury
- Date Received
- April 30, 2024
- Date of Event
- April 3, 2024
- Report Date
- April 30, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030816659
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 10-APR-2024. LOT 1902811: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2019. EXPIRATION DATE: 2024-05-22. 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 ABOUT 1 YEAR AND 4 MONTHS AFTER 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 |
|---|---|---|---|---|---|---|---|
| 2080508 | GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 1902811 | 07630030816659 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |