FDA Adverse Event
Injury
Summary report: N
AMIS SHOE
MDR report key: 20244206
·
Received September 18, 2024
Report
- Report Number
- 3005180920-2024-00745
- Event Type
- Injury
- Date Received
- September 18, 2024
- Date of Event
- August 14, 2024
- Report Date
- October 31, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- FWX
- UDI-DI
- 07630040736206
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. THE AMIS SHOE IS COMPLAINT AND WORKS PROPERLY; IT IS NOT POSSIBLE TO FIND THE CAUSE OF THE EVENT, BUT IT IS UNLIKELY THAT THE EVENT WAS DUE TO THE DEVICE.
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2024. LOT 2352015: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUNE-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
FIBULA FRACTURE DETECTED 5 DAYS AFTER AMIS SURGERY. NO ADDITIONAL SURGERY PLANNED. THE SURGEON REPORTS THAT THE FRACTURE HAPPENED WHILE THE PATIENT'S FOOT WAS IN THE AMIS SHOE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1490150 | AMIS SHOE | SHOE FOR AMIS HIP SURGERY | FWX | MEDACTA INTERNATIONAL SA | 2352015 | 07630040736206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |