FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L
MDR report key: 8770629
·
Received July 9, 2019
Report
- Report Number
- 3005180920-2019-00551
- Event Type
- Injury
- Date Received
- July 9, 2019
- Date of Event
- June 10, 2019
- Report Date
- July 9, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862601
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 17 JUN 2019: LOT 173772: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2017. EXPIRATION DATE: 17-AUG-2022. 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, MORE THAN ONE YEAR AFTER PRIMARY SURGERY, COMPLAINING OF MID FLEXION INSTABILITY. THE SURGEON REVISED A 11MM POLY WITH A 14MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565740 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L | KNEE TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 173772 | 07630030862601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |