FDA Adverse Event
Injury
Summary report: N
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM
MDR report key: 17190244
·
Received June 23, 2023
Report
- Report Number
- 3005180920-2023-00450
- Event Type
- Injury
- Date Received
- June 23, 2023
- Date of Event
- May 25, 2023
- Report Date
- June 23, 2023
- 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 01 JUNE 2023: LOT 183190: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JULY-2018. EXPIRATION DATE: 2023-07-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 4 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRIMARY WAS FROM A COMPETITOR AND THE SURGEON REVISED THE COMPETITOR TO MEDACTA REVISION COMPONENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1447800 | GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM | KNEE TIBIAL INSERT REVISION SYSTEM | JWH | MEDACTA INTERNATIONAL SA | 02.07.0312SCF | 183190 | 07630030817175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |