FDA Adverse Event
Injury
Summary report: N
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM
MDR report key: 17412885
·
Received July 28, 2023
Report
- Report Number
- 3005180920-2023-00631
- Event Type
- Injury
- Date Received
- July 28, 2023
- Date of Event
- July 17, 2023
- Report Date
- July 28, 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 26 JULY 2023: LOT 1904796: 60 ITEMS MANUFACTURED AND RELEASED ON 11-JULY-2019. EXPIRATION DATE: 2024-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 44 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 2 YEARS 9 MONTHS AFTER 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 |
|---|---|---|---|---|---|---|---|
| 1968386 | GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM | KNEE FIXED TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 1904796 | 07630030817175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |