FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/13 MM R
MDR report key: 7086825
·
Received December 6, 2017
Report
- Report Number
- 3005180920-2017-00724
- Event Type
- Injury
- Date Received
- December 6, 2017
- Date of Event
- November 6, 2017
- Report Date
- December 6, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862670
- 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 (B)(4) 2017. LOT 163079: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 AUGUST 2016. EXPIRATION DATE: 2021-08-17. 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
ONE MONTH AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT INLAY FOR INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 867595 | GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/13 MM R | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 163079 | 07630030862670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |