FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM LEFT
MDR report key: 7057077
·
Received November 23, 2017
Report
- Report Number
- 3005180920-2017-00691
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- October 24, 2017
- Report Date
- November 23, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862533
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 20 NOVEMBER 2017. LOT 142490: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 AUGUST 2014. EXPIRATION DATE: 2019-06-30. 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 DUE TO DISLOCATION ANTERIOR TO THE TIBIA. THE CAUSE OF DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE POLY FROM A SIZE 2 13MM MOVING TO A SIZE 2 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834351 | GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM LEFT | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 142490 | 07630030862533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |