FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L
MDR report key: 17413268
·
Received July 28, 2023
Report
- Report Number
- 3005180920-2023-00586
- Event Type
- Injury
- Date Received
- July 28, 2023
- Date of Event
- July 11, 2023
- Report Date
- July 28, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030819889
- 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 13-JUL-2023: LOT 162178: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUN-2016. EXPIRATION DATE: 2021-05-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 6 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA. THE SURGEON REVISED THE TIBIA, FEMUR AND INSERT AND IMPLANTED A REVISION TIBIA WITH A STEM AND A REVISION FEMUR WITH A STEM AS WELL AS A SEMICONSTRAINED INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2325734 | GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L | TIBIAL TRAY FIXED | JWH | MEDACTA INTERNATIONAL SA | 162178 | 07630030819889 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |