FDA Adverse Event
Injury
Summary report: N
TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM R
MDR report key: 7344700
·
Received March 16, 2018
Report
- Report Number
- 3005180920-2018-00149
- Event Type
- Injury
- Date Received
- March 16, 2018
- Date of Event
- February 14, 2018
- Report Date
- March 16, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826627
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 15 MARCH 2018; LOT 162636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 2016 EXPIRATION DATE: 2021-07-21 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 SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188660 | TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM R | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 162636 | 07630030826627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |