AFX™ Femoral Implant CM-2509AFXRecalls & reported problems
Cayenne Medical, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887868380365), received between Oct 21, 2021 and Jun 10, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Failure of Implant2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22178954 ↗MalfunctionAug 5, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 19905524 ↗MalfunctionJan 16, 2024Fracture; Fracture
IT WAS FURTHER REPORTED, ALL BROKEN PARTS WERE REMOVED SUCCESSFULLY FROM THE PATIENT IMMEDIATELY AFTER THE IMPLANT FRACTURED. ANOTHER DEVICE WAS LOADED AND IMPLANTED SUCCESSFULLY WITHOUT ANY ISSUES. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18520387 ↗MalfunctionJul 13, 2022Fracture; Fracture
IT WAS REPORTED DURING A RIGHT SIDE HS TENDON AUTO ACL RECONSTRUCTION SURGERY THAT THE IMPLANT WAS FRACTURED. DURING TENSIONING OF THE GRAFT ON THE TIBIAL SIDE, THE GRAFT HAD SLIPPED AND THE IMPLANT WAS PULLED OUT. IT WAS NOTICED THAT THE BLACK SCREW OF THE ANCHOR WAS BROKEN. IMPLANT WAS REMOVED AND A BACKUP WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15007117 ↗MalfunctionOct 21, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY WHEN IMPLANTING THE AFX BROKE AS IT WAS PUSHED INTO PLACE. A SECOND AFX WAS OPENED AND USED TO COMPLETE THE SURGERY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12671951 ↗
Other Fastener, Fixation, Nondegradable, Soft Tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page