APEX 3D Total Ankle Replacement System P10-251-TLR2-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889795060280), received between Oct 15, 2025 and Mar 26, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Implant subsidence” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence

  IT WAS FURTHER REPORTED THAT APPROXIMATELY 17 MONTHS POST IMPLANTATION OF A RIGHT TOTAL ANKLE ARTHROPLASTY, THE PATIENT PRESENTED WITH PAIN AND SWELLING AND UNDERWENT A REVISION WHERE SIGNIFICANT SCAR TISSUE WAS RESECTED FROM THE ANTERIOR JOINT, SIGNIFICANT OSTEOPHYTES WERE DEBRIDED FROM THE MEDIAL AND LATERAL GUTTERS, AND THE POLY WAS EXCHANGED. A COMPETITOR SCREW WAS PLACED TO HELP SUPPORT THE MEDIAL MALLEOLUS. DURING THE REVISION, IT WAS NOTED THAT THE TIBIAL AND TALAR COMPONENTS WERE WELL-FIXED. UPON EXAMINATION OF THE INTRAOPERATIVE X-RAYS, IT WAS NOTED THAT THE STRESS REACTION OF THE MEDIAL TIBIA WAS SUBSTANTIAL COMPARED TO PREOPERATIVE X-RAYS, AND IT WAS BELIEVED THAT THE MEDIAL PORTION OF THE TALUS AND THE MEDIAL PORTION OF THE TIBIA HAD SIGNIFICANT IMPINGEMENT AND THIS WAS CAUSING STRESS CHANGE OF THE DISTAL TIBIA. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Exostosis (bone); Joint Impingement; Osteopenia/ Osteoporosis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 24705359 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST IMPLANTATION OF A RIGHT ANKLE PROSTHESIS SYSTEM, THE PATIENT PRESENTED WITH A NONDISPLACED POSTERIOR TALUS FRACTURE. PATIENT WAS TREATED WITH CAM BOOT, ELEVATION, ICE AND ORAL ANALGESICS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Periprosthetic fracture

  MAUDE report 24688733 ↗
• InjuryOct 15, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS FURTHER REPORTED THAT APPROXIMATELY 5 MONTHS POST IMPLANTATION OF A RIGHT TOTAL ANKLE ARTHROPLASTY, THE PATIENT DEVELOPED WOUND DEHISCENCE, ERYTHEMA, AND DRAINAGE, AND WAS ADMITTED FOR OSTEOMYELITIS WITH SECONDARY CELLULITIS, EXPOSED TENDON WITH ODOR, AND PAIN. PATIENT UNDERWENT AN I&D TO BONE AND NECROTIC TISSUE, AND COMPLETED A TENDON TRANSFER AND WOUND CLOSURE. INTRA-OP CULTURES WERE POSITIVE FOR PREVOTELLA AND THE POLY WAS EXCHANGED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Cellulitis; Erythema; Fluid Discharge; Medical device site infection; Necrosis; Osteomyelitis; Pain; Skin Infection; Wound Dehiscence; Wound Odor

  MAUDE report 23300702 ↗