LEGEND II 2490-95-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295125952), received between Aug 8, 2018 and Dec 11, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR IT BAND TENDINITIS. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 26/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT. DEPUY SYNTHES PRODUCT USED: CATALOG ID: 151820032, LOT ID: 3802592, COMPONENT TYPE: PATELLAR, DESCRIPTION: ATTUNE MEDIAL DOME PAT 32MM; CATALOG ID: 151820308, LOT ID: JP9042, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 3 8MM; CATALOG ID: 150400103, LOT ID: 8093073, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE C/RET FEM LT SZ 3 CEMENTED; CATALOG ID: 150670003, LOT ID: 9854210, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE FB CEMENTED TIBIAL BASE SIZE 3; CATALOG ID: 249095000, LOT ID: M0476R, COMPONENT TYPE: PIN, DESCRIPTION: AMK FIXATION PINS 1/8 DIA X 3; CATALOG ID: 950502303, LOT ID: M1312Z, COMPONENT TYPE: ACC, DESCRIPTION: SIGMA LCS HIGH PERFORMANCE, STERILE THREADED HEADED PINS; CATALOG ID: 3312040, LOT ID: 3807417, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET CMW 1 40G.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20903518 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE INFECTION. IMPLANT WAS REMOVED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20053995 ↗
• MalfunctionAug 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  WHEN ATTEMPTING TO PIN THE ANATOMIC RESECTION GUIDE, THE LEGEND II FIXATION PIN BECAME STUCK IN THE PIN HOLE AND WAS UNABLE TO BE REMOVED. THE SURGEON PINNED THE CUTTING GUIDE USING THE REMAINING PINHOLE. THERE WAS NO IMPACT TO THE PATIENT, AND NO DELAY TO SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929206 ↗
• MalfunctionJul 7, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DRILL BIT JAMMED INSIDE CUTTING GUIDE. NO FRAGMENTS GENERATED AND GUIDE STILL USED BUT WILL NEED REPLACING. NO TIME ADDED TO THE CASE. NO PATIENT DETAILS OR X-RAYS AVAILABLE. NO SURGERY DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129596 ↗
• MalfunctionOct 1, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LEGEND 2 FIXATION PIN GOT STUCK ON THE CUTTING BLACK WHILE TRYING TO PIN TO THE HUMERAL HEAD. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613073 ↗
• MalfunctionMar 6, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE THREADED PIN BECAME STUCK IN SIDE HOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8395508 ↗
• MalfunctionFeb 20, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILE PINNING THE CUTTING GUIDE, A FIXATION PIN BECAME LODGED IN THE GUIDE PREVENTING THE USE OF THE JIG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354456 ↗
• MalfunctionFeb 4, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PIN BECAME LODGED IN THE CUT BLOCK DURING REMOVAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301691 ↗
• MalfunctionFeb 4, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE A FIXATION PIN FROM THE GLOBAL UNITE ANATOMICAL PAN BECAME STUCK IN THE FUNERAL CUTTING JIG (RIGHT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301087 ↗
• MalfunctionAug 8, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PIN BECAME LODGED IN THE RESECTION GUIDE DURING PIN REMOVAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761345 ↗