FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 6 R
MDR report key: 14268869
·
Received May 3, 2022
Report
- Report Number
- 3005180920-2022-00336
- Event Type
- Injury
- Date Received
- May 3, 2022
- Date of Event
- April 7, 2022
- Report Date
- May 2, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030819957
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 08 APRIL 2022: LOT 2013153: 53 ITEMS MANUFACTURED AND RELEASED ON 23-APRIL-2021. EXPIRATION DATE: 2026-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
REVISION SURGERY AT 6 MONTHS FROM PRIMARY DUE TO TIBIAL TRAY FIXED CEMENTED LOOSENING. TIBIAL TRAY AND LINER SWAPPED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1318813 | GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 6 R | TIBIAL TRAY FIXED CEMENTED | JWH | MEDACTA INTERNATIONAL SA | 02.07.1206R | 2013153 | 07630030819957 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |