FDA Adverse Event
Injury
Summary report: N
GMK-REVISION 02.07.0312SCF FIXED TIBIAL INSERT SC SIZE 3/12MM
MDR report key: 19573512
·
Received June 20, 2024
Report
- Report Number
- 3005180920-2024-00410
- Event Type
- Injury
- Date Received
- June 20, 2024
- Date of Event
- May 21, 2024
- Report Date
- June 20, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030817175
- 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 23 MAY 2024 LOT 2100662: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2024. EXPIRATION DATE: 2029-01-01. 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 5 MONTHS 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 |
|---|---|---|---|---|---|---|---|
| 1603805 | GMK-REVISION 02.07.0312SCF FIXED TIBIAL INSERT SC SIZE 3/12MM | KNEE FIXED TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2100662 | 07630030817175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Required Intervention |