FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L
MDR report key: 9007203
·
Received September 12, 2019
Report
- Report Number
- 3005180920-2019-00764
- Event Type
- Injury
- Date Received
- September 12, 2019
- Date of Event
- August 15, 2019
- Report Date
- September 12, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030819889
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 27 AUGUST 2019: LOT 150939: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A COLLAPSED BONE UNDER THE TIBIA. THE SURGEON REVISED THE INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT 3 YEARS AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801611 | GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L | TIBIAL TRAY FIXED CEMENTED | JWH | MEDACTA INTERNATIONAL SA | 150939 | 07630030819889 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |