FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R
MDR report key: 8353647
·
Received February 20, 2019
Report
- Report Number
- 3005180920-2019-00069
- Event Type
- Injury
- Date Received
- February 20, 2019
- Date of Event
- January 22, 2019
- Report Date
- February 20, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826382
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 18 FEBRUARY 2019: LOT 171072: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2017. EXPIRATION DATE: 2022-05-14. 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 1 MONTH AFTER PRIMARY DUE TO INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148108 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 171072 | 07630030826382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |