FDA Adverse Event
Injury
Summary report: N
MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 - LATERAL - 8MM
MDR report key: 15273676
·
Received August 23, 2022
Report
- Report Number
- 3005180920-2022-00649
- Event Type
- Injury
- Date Received
- August 23, 2022
- Date of Event
- July 28, 2022
- Report Date
- August 23, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- HSX
- UDI-DI
- 07630040720960
- PMA / PMN Number
- K183029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 04 AUGUST 2022. LOT 2101735: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-APR-2021. EXPIRATION DATE: 2026-04-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS 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 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN 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 |
|---|---|---|---|---|---|---|---|
| 2102196 | MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 - LATERAL - 8MM | KNEE UNICOMPARTIMENTAL INSERT | HSX | MEDACTA INTERNATIONAL SA | 02.18.IF5.08.LLRL | 2101735 | 07630040720960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |