FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L
MDR report key: 19415228
·
Received May 29, 2024
Report
- Report Number
- 3005180920-2024-00376
- Event Type
- Injury
- Date Received
- May 29, 2024
- Date of Event
- May 6, 2024
- Report Date
- May 29, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- 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 29 MAY 2024: LOT 150340: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2015. EXPIRATION DATE: 2022-02-28. 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
REVISION SURGERY DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. AT ABOUT 5 YEARS AND 4 MONTHS POST PRIMARY THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586582 | GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L | KNEE TIBIAL TRAY | JWH | MEDACTA INTERNATIONAL SA | 150340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention |