AGILITY 1555-35-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295058755), received between Nov 9, 2017 and Feb 23, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 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.

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.

• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2003, THE PATIENT UNDERWENT A PRIMARY RIGHT TOTAL ANKLE REPLACEMENT. DEPUY PRODUCTS WERE IMPLANTED ALONG WITH TWO UNKNOWN MANUFACTURER SCREWS. THE SURGEON INDICATED AN INTRA-OPERATIVE COMPLICATION OF NICKING ONE OF THE VEINS IN THE NEUROVASCULAR BUNDLE, THE NICK WAS CAUTERIZED AND THEN TIED OFF WITH NO INDICATED RESULTING PATIENT, INJURY, HARM, OR RESULTING COMPLICATION. THE EVENT OCCURRED PRIOR TO THE USE OF ANY DEPUY PRODUCT. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT ANKLE REMOVAL OF TOTAL ANKLE COMPONENTS AND PLACEMENT OF COMPETITOR NAILS AND FUSION OF ADJACENT BONES. ALL DEPUY PRODUCTS WERE REMOVED. PRIOR TO THE PROCEDURE, THE PATIENT WAS EXPERIENCING THE FOLLOWING ADVERSE SYMPTOMS: PAIN, DECREASED RANGE OF MOTION, EDEMA, DIFFICULTY WALKING, OSTEOLYSIS, NUMBNESS, WEAKNESS, INSTABILITY, CYSTS, STIFFNESS, AND LOOSENING OF THE ENTIRE SYSTEM. THE SURGEON ALSO INDICATED REMOVING TWO STRIPPED SCREWS (OF UNKNOWN MANUFACTURER). DOI: (B)(6) 2003. DOR: (B)(6) 2019; RIGHT ANKLE.

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Numbness; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 11365817 ↗
• InjuryFeb 23, 2021Naturally Worn; Naturally Worn

  ON (B)(6) 2003, THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL ANKLE REPLACEMENT. DEPUY PRODUCTS WERE IMPLANTED ALONG WITH TWO UNKNOWN MANUFACTURER SCREWS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2008, THE PATIENT UNDERWENT A LEFT ANKLE POLY REVISION/EXCHANGE AND DEBRIDEMENT TO ADDRESS POLY WEAR, CYSTS, PAIN, NUMBNESS, INFLAMMATION, SWELLING, ADHESIONS, AND INFECTION. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS LEADING UP TO THE REVISION OPERATION. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2003. DOR: (B)(6) 2008; LEFT ANKLE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Inflammation; Numbness; Pain; Swelling/ Edema

  MAUDE report 11365535 ↗
• InjuryNov 9, 2017Naturally Worn; Naturally Worn

  DER STATES THAT THE SURGEON CLEANED UP THE ANKLE JOINT BECAUSE PATIENT HAD GOUT AND PUT IN A NEW INSERT.

  Patient problems: No Information

  MAUDE report 7016771 ↗