FDA Adverse Event
Injury
Summary report: N
MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM
MDR report key: 16635898
·
Received March 29, 2023
Report
- Report Number
- 3005180920-2023-00205
- Event Type
- Injury
- Date Received
- March 29, 2023
- Date of Event
- February 28, 2023
- Report Date
- March 29, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- HSX
- UDI-DI
- 07630030896217
- PMA / PMN Number
- K162084
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 10 MARCH 2023 LOT 2013314: (B)(4) MANUFACTURED AND RELEASED ON 25-MARCH-2021. EXPIRATION DATE: 2026-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 20 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1766618 | MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM | KNEE TIBIAL INSERT FIX | HSX | MEDACTA INTERNATIONAL SA | 02.18.IF5.08.LM | 2013314 | 07630030896217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |