FDA Adverse Event
Injury
Summary report: N
MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM
MDR report key: 13340928
·
Received January 25, 2022
Report
- Report Number
- 3005180920-2022-00042
- Event Type
- Injury
- Date Received
- January 25, 2022
- Date of Event
- December 10, 2021
- Report Date
- December 29, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- HSX
- UDI-DI
- 07630030896101
- PMA / PMN Number
- K162084
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2021. LOT 2103536: 35 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-APR-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
THE PATIENT CAME IN 19 DAYS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559534 | MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM | PARTIAL KNEE TIBIAL INSERT | HSX | MEDACTA INTERNATIONAL SA | 02.18.IF4.08.RM | 2103536 | 07630030896101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |