FDA Adverse Event
Injury
Summary report: N
CUSTOM DEVICE - RIGHT FEMORAL BONE ANCHORED OSSEOINTEGRATION IMPLANT
MDR report key: 24728765
·
Received March 30, 2026
Report
- Report Number
- 3029890418-2026-00003
- Event Type
- Injury
- Date Received
- March 30, 2026
- Report Date
- March 30, 2026
- Manufacturer
- ALM ORTHO, INC
- Product Code
- PJY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A REVIEW OF THE DEVICE HISTORY RECORD DID NOT FIND ANY DESIGN OR MANUFACTURING RELATED DEFECTS. THE PARTS HAVE NOT BEEN RETURNED TO ALM ORTHO FOR FURTHER INVESTIGATION. THE CAUSE IS UNKNOWN AT THIS TIME.
Description of Event or Problem · 0
ON (B)(6) 2026 THE COMPANY RECEIVED NOTIFICATION FROM THE SURGEON THAT A PATIENT EXPERIENCED A DEVICE FAILURE. THE PATIENT WAS PERFORMING A ROUTINE ACTIVITY, SPECIFICALLY TURNING AROUND WHILE OPERATING A LEAF BLOWER. THE SHAFT OF THE TRANSFEMORAL BONE ANCHORED IMPLANT FRACTURED AT ITS BASE RESULTING IN SEPARATION OF THE IMPLANT FROM THE DISTAL PORTION. THE DEVICE WAS EXPLANTED ON (B)(6) 2026.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 788822 | CUSTOM DEVICE - RIGHT FEMORAL BONE ANCHORED OSSEOINTEGRATION IMPLANT | RIGHT FEMORAL BONE ANCHORED OSSEOINTEGRATED IMPLANT | PJY | ALM ORTHO, INC | 050625.03A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Required Intervention |