FDA Adverse Event
Injury
Summary report: N
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 L
MDR report key: 7946590
·
Received October 9, 2018
Report
- Report Number
- 3005180920-2018-00774
- Event Type
- Injury
- Date Received
- October 9, 2018
- Date of Event
- September 11, 2018
- Report Date
- October 9, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030819872
- 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 09 OCTOBER 2018; LOT 150343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 APRIL 2015. EXPIRATION DATE: 2020-02-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN 3 YEARS AFTER PRIMARY. THE SURGEON DETERMINED THAT THE PATIENT WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE SURGEON REVISED THE TIBIA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. NEW IMPLANTS USED: REVISION TIBIAL TRAY (REF. 02.07.0682R LOT 176136) AND 20 MM INSERT (REF. 02.07.0220FUC LOT 145639).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 788841 | GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 L | KNEE TIBIAL TRAY CEMENTED | JWH | MEDACTA INTERNATIONAL SA | 150343 | 07630030819872 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |