FDA Adverse Event
Injury
Summary report: N
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM
MDR report key: 18171486
·
Received November 20, 2023
Report
- Report Number
- 3005180920-2023-00887
- Event Type
- Injury
- Date Received
- November 20, 2023
- Date of Event
- October 25, 2023
- Report Date
- November 20, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- HSX
- UDI-DI
- 07630030895609
- PMA / PMN Number
- K162084
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 170780: (B)(4) MANUFACTURED AND RELEASED ON 24-MAY-2017. EXPIRATION DATE: 2025-05-10.NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT 5 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2069244 | MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM | KNEE FEMORAL COMPONENT | HSX | MEDACTA INTERNATIONAL SA | 170780 | 07630030895609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |