FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R
MDR report key: 8943842
·
Received August 29, 2019
Report
- Report Number
- 3005180920-2019-00722
- Event Type
- Injury
- Date Received
- August 29, 2019
- Date of Event
- August 1, 2019
- Report Date
- August 29, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030819872
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 7 AUGUST 2019 LOT 162678: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2016. EXPIRATION DATE: 2021-05-03. 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
REVISION SURGERY PERFORMED, 3 YEARS AFTER PRIMARY SURGERY, DUE TO THE TIBIAL TRAY LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737480 | GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R | KNEE TIBIAL TRAY FIXED CEMENTED | JWH | MEDACTA INTERNATIONAL SA | 162182 | 07630030819872 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |