FDA Adverse Event
Injury
Summary report: N
MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM
MDR report key: 9989993
·
Received April 23, 2020
Report
- Report Number
- 3005180920-2020-00256
- Event Type
- Injury
- Date Received
- April 23, 2020
- Date of Event
- March 27, 2020
- Report Date
- April 23, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- HSX
- UDI-DI
- 07630030896101
- PMA / PMN Number
- K162084
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 06 APRIL 2020: LOT 1903777: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2019. EXPIRATION DATE: 2024-07-10. 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, 3 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 454955 | MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM | PARTIAL TIBIAL INSERT | HSX | MEDACTA INTERNATIONAL SA | 02.18.IF4.08.RM | 1903777 | 07630030896101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |