ALM ORTHO INC - CUSTOM DEVICE - LEFT FEMORAL AUGMENT
Report
- Report Number
- 3029890418-2025-00002
- Event Type
- Injury
- Date Received
- October 21, 2025
- Report Date
- January 9, 2026
- Manufacturer
- ALM ORTHO, INC
- Product Code
- PJY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: THE SURGEON REPORTED THAT THE PROXIMAL CONNECTION BETWEEN 060325.03Z AND 060325.03A HELD TOGETHER BY PROXIMAL SCREWS DISCONNECTED. AT THE TIME OF THE INCIDENT, THE PATIENT WAS USING ONE CRUTCH AND HAD RECENTLY BECOME MOBILE. THE SYSTEM WAS INTENDED TO BE USED AS A LARGE FEMORAL AUGMENT TO PRESERVE THE PATIENT'S REMAINING PROXIMAL AND DISTAL FEMUR. SINCE THIS WAS A REVISION TO A CUSTOM DEVICE, IT WAS DECIDED BY THE FAMILY AND THE SURGEON THAT THE BEST COURSE OF ACTION MOVING FORWARD WAS TO REMOVE THE CURRENT ALM DEVICE AND REPLACE IT WITH A TOTAL FEMORAL REPACLEMENT. REVIEW OF THE DEVICE HISTORY RECORD DID NOT FIND ANY DESIGN OR MANUFACTURING DEFECTS. THE PARTS WILL NOT BE RETURNED FOR EVALUATION. THE RISK OF SCREW DISCONNECTION WAS EVALUATED AND NO FURTHER RISK MITIGATION REQUIRED. THIS IS ONLY THE SECOND TIME THIS TYPE OF INCIDENT HAS BEEN OBSERVED. IT IS BELIEVED TO BE AN ISOALTED INCIDENT AND MAY BE RELATED TO THE PATIENT'S CONDITION AND NOT INDICATIVE OF A BROADER TREND.
THE REVISION SURGERY HAS NOT BEEN CONDUCTED AS OF THE DATE OF THIS REPORT. THEREFORE, THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT FIND ANY DESIGN OR MANUFACTURING DEFECTS. THE RISK OF SCREW DISCONNECTION WAS EVALUATED DURING THE RISK ASSESSMENT. ADDITIONAL COMPONENTS WILL BE PROVIDED AFTER DISCUSSIONS WITH THE SURGEON ALONG WITH REPLACEMENT COMPONENTS TO FURTHER MITIGATE THE SCREW DISCONNECTION. THE COMPANY HAS NOT SEEN THIS TYPE OF INCIDENT IN THE PAST AND IT IS DETERMINED TO BE AN ISOLATED INCIDENT.
THIS IS AN UPDATED TO A PREVIOUSLY REPORTED INCIDENT. ORIGINAL REPORT - ON (B)(6) 2025 THE COMPANY WAS SENT IMAGES CONFIRMING A DISCONNECTION BETWEEN DISTAL SEGMENT AND CENTRAL SEGMENT THAT WAS NOT PRESENT IN THE INITIAL POST-OPERATIVE X-RAYS. THE PHYSICIAN INDICATED THAT A REVISION SURGERY WOULD NEED TO BE PERFORMED. THE PHYSICIAN WORKED WITH THE COMPANY TO ADJUST THE DEVICE TO FURTHER MITIGATE THE RISK OF SCREW DISCONNECTION. A REVISION SURGERY IS TO BE SCHEDULED. THERE WERE NO REPORTS OF PATIENT INJURY OR PERMANENT FUNCTIONAL IMPAIRMENT RELATED TO THE EVENT. ADDITIONAL INFORMATION / UPDATE: A NEW COMPONENT WAS DESIGNED WITH A REDUCED RADIUS OF CURVATURE AND AN 8 DEGREE VARUS VALGUS CORRECTION TO MITIGATE THE RISK OF SCREW SEPARATION AND IMPROVE OVERALL DEVICE STABILITY. THE SUBSEQUENT IMPLANTS WERE MANUFACTURED UNDER BUILD NUMBER (B)(4) ON (B)(6) 2025 AND WERE IMPLANTED ON (B)(6) 2025. IT WAS REPORTED TO ALM THROUGH EMAIL WITH DR (B)(6) ON (B)(6) 2025 THAT THE PROXIMAL CONNECTION HELD TOGETHER BY A PROXIMAL SCREW DISCONNECTED. AT THE TIME OF THE INCIDENT, THE PATIENT WAS USING ONE CRUTCH AND HAD RECENTLY BECOME MOBILE. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PERMANENT FUNCTIONAL IMPAIRMENTS RELATED TO THIS EVENT.
ON 09/29/2025 THE COMPANY WAS SENT IMAGES CONFIRMING A DISCONNECTION BETWEEN DISTAL SEGMENT AND CENTRAL SEGMENT THAT WAS NOT PRESENT IN THE INITIAL POST-OPERATIVE X-RAYS. THE PHYSICIAN INDICATED THAT A REVISION SURGERY WOULD NEED TO BE PERFORMED. THE PHYSICIAN WORKED WITH THE COMPANY TO ADJUST THE DEVICE TO FURTHER MITIGATE THE RISK OF SCREW DISCONNECTION. A REVISION SURGERY IS TO BE SCHEDULED. THERE WAS NO REPORTS OF PATIENT INJURY OR PERMANENT FUNCTIONAL IMPAIRMENT RELATED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1841499 | ALM ORTHO INC - CUSTOM DEVICE - LEFT FEMORAL AUGMENT | PRODUCT CODE PJY | PJY | ALM ORTHO, INC | 06030325.03D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Male | Required Intervention |