ALM ORTHO TRANSTIBIAL BONE ANCHORED OSSEOINTEGATED IMPLANT
Received Dec 21, 2025 · Event occurred Nov 26, 2025
Report 3029890418-2025-00003 · MDR key 23861047
Device
Generic name
Transtibial Implant Customer Device
Manufacturer
Alm Ortho, IncModel number
121823.04ALot number
256-001-003
Product problems
- Fracture
- Fracture
Patient
48 YR · Female
- Periprosthetic fracture
- Periprosthetic fracture
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE DEVICE HISTORY RECORD DID NOT FIND ANY DESIGN OR MANUFACTURING DEFECTS. FURTHER INVESTIGATION WILL BE COMPLETED UPON RECEIPT OF THE EXPLANTED DEVICE AND PERTINENT FINDINGS WILL BE UPDATED. BASED ON HISTORICAL DATA, THIS HAS BEEN DETERMINED TO BE AN ISOLATED INCIDENT.
Description of Event or Problem
THE DEVICE WAS IMPLANTED ON (B)(6) 2024 WITHOUT INCIDENT. ON (B)(6) 2025 THE COMPANY WAS NOTIFIED BY THE PATIENT'S SURGEON THAT THERE WAS A FRACTURED IMPLANT. THE COMPANY RECEIVED CONFIRMATORY IMAGING OF THE BROKEN IMPLANT WITH IMAGES OF THE DISTAL IMPLANT FRAGMENT ON 11/22/2025. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2025.