FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L
MDR report key: 7897534
·
Received September 21, 2018
Report
- Report Number
- 3005180920-2018-00710
- Event Type
- Injury
- Date Received
- September 21, 2018
- Date of Event
- August 22, 2018
- Report Date
- September 21, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826733
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2018; LOT 161371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JUNE 2016. EXPIRATION DATE: 2021-05-17; 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 AFTER ABOUT 2 YEARS DUE TO INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 740397 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 161371 | 07630030826733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |