FDA Adverse Event Injury Summary report: N

ALM ORTHO - CUSTOM DEVICE - TRANSFEMORAL BONE ANCHORED OSSEOINTEGRATION IMPLANT

MDR report key: 24213051 · Received January 29, 2026

Report

Report Number: 3029890418-2026-00001
Event Type: Injury
Date Received: January 29, 2026
Report Date: January 29, 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

THE PATIENT UNDERWENT EXPLANTATION SURGERY. THE COMPANY IS UNAWARE OF ANY SIGNIFICANT STATUS CHANGE WITH THE PATIENT CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING SUBSEQUENT CLINICAL MANAGEMENT OR PATIENT OUTCOMES. A REVIEW OF THE PRODUCTION RECORDS DID NOT FIND ANY DESIGN OR MANUFACTURING DEFECTS. THE PARTS HAVE NOT BEEN RETURNED FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Description of Event or Problem · 0

THE ORIGINAL SURGERY WAS ON (B)(6) 2025 TO IMPLANT A CUSTOM DEVICE (TRANSFEMORAL BONE ANCHORED OSSEOINTEGRATION IMPLANT). ON (B)(6) 2026, THE COMPANY WAS INFORMED BY THE SURGEON THAT THE PATIENT EXPERIENCED A DEVICE FAILURE WHILE WALKING. THE REPORTED FAILURE MODE INDICATES THAT THE SHAFT OF THE TRANSFEMORAL BONE ANCHORED IMPLANT FRACTURED AT ITS BASE, RESULTING IN SEPARATION OF THE IMPLANT FROM THE DISTAL PORTION. AS A RESULT OF THIS EVENT, AN EXPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2026 AND THE DEVICE WAS REMOVED. THERE WERE NO REPORTS OF PERMANENT FUNCTIONAL IMPAIRMENT RELATED TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
270837	ALM ORTHO - CUSTOM DEVICE - TRANSFEMORAL BONE ANCHORED OSSEOINTEGRATION IMPLANT	OSSEOANCHORED PROSTHESES FOR THE REHABILITATION OF TRANSFEMORAL AMPUTEES	PJY	ALM ORTHO, INC	071524.03A

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR	Female	Required Intervention