NA 210080Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00848486031879), received between Aug 10, 2018 and Nov 20, 2023 — classified as 74 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (40 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2023Material Frayed; Sharp Edges; Material Frayed; Sharp Edges

  THE EDGE OF THE PLASTIC HAS BEEN FRAYING AND HAS CUT STAFF TO THE POINT OF BLEEDING CASE TYPE / APPLICATION: TKA.

  Patient problems: Blister; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168176 ↗
• MalfunctionDec 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  LEG POSITIONER BOOT BECAME DETACHED FROM THE METAL SPIKE. SURGICAL DELAY: = 15 MINUTES. CASE TYPE / APPLICATION: TKA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992250 ↗
• MalfunctionAug 31, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  DR (B)(6) WAS USING THE MAKO TKR LEG HOLDER AS PART OF HIS USUAL MAKO TKR PROCEDURE. DURING IMPLANTATION (IMPACTION) OF THE TIBIAL BASEPLATE, THE BOOT SNAPPED OFF THE BRACKET THAT HOLDS THE STAINLESS STEEL CONE PEG, CAUSING THE LEG TO DROP SUDDENLY. NO INJURY WAS SUSTAINED TO THE PATIENT OR THE SURGEON, HOWEVER THE LEG HOLDER IS BROKEN FROM STANDARD USE. UPDATE 18 AUGUST 2020: 2-3 MINUTE SURGICAL DELAY AS THEY ADJUSTED POSITION MANUALLY TO POSITION THE LEG FOR THE TIBIAL IMPLANTATION AND SKIN CLOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10474872 ↗
• MalfunctionApr 1, 2020Material Frayed; Material Frayed

  IT WAS NOTICED THAT THE CARBON BOOT WAS CRACKING/SPLINTERING ALONG A TOP LIP DURING PRE-SURGERY CHECK. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9911560 ↗
• MalfunctionMar 26, 2020Crack; Material Frayed; Crack; Material Frayed

  BOOT IS CRACKED AND SPLINTERING. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9883854 ↗
• MalfunctionMar 26, 2020Break; Material Frayed; Break; Material Frayed

  UPPER PART OF CARBON FIBER BOOT IS BREAKING. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9883849 ↗
• MalfunctionMar 25, 2020Material Frayed; Sharp Edges; Material Frayed; Sharp Edges

  FRAYING AND SHARP EDGES ON BOOT. SURGEON WORRIED ABOUT CUTTING PATIENT. PATIENT WAS NOT CUT. NO HARM WAS DONE. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9876713 ↗
• MalfunctionMar 25, 2020Material Frayed; Material Frayed

  SURGEON NOTICED THAT LEG POSITIONER BOOT WAS "FRAYING" CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9876712 ↗
• MalfunctionMar 16, 2020Sharp Edges; Sharp Edges

  NOTICED DURING DECONTAMINATION PROCESS. CARBON FIBERS AT TOP PORTION OF BOOT APPEAR TO BE FRAYING/SPLINTERING. BOOT NEEDS REPLACEMENT. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9836935 ↗
• MalfunctionMar 12, 2020Material Frayed; Material Frayed

  WHEN THE BOOT WAS OPENED FOR THE CASE THE SCRUB NOTICED THE BOOT WAS FRAYED AND SHARP. CASE TYPE: TKA.

  Patient problems: No Patient Involvement

  MAUDE report 9827489 ↗
• MalfunctionMar 9, 2020Material Frayed; Material Frayed

  BLACK BOOT IS STARTING TO FRAY NEAR THE TOE, CAUSING SPLINTERS. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9806218 ↗
• MalfunctionFeb 27, 2020Material Frayed; Material Frayed

  SURGEON BROUGHT TO ATTENTION THAT THE LEG HOLDER HAD CHIPPED AND HAD AN EXPOSED SHARP EDGE. CASE TYPE: TKA.

  Patient problems: No Patient Involvement

  MAUDE report 9765805 ↗
• MalfunctionFeb 25, 2020Material Frayed; Material Frayed

  BLACK BOOT IS FRAYING ON THE EDGES AND CUT OPEN A SURGEONS GLOVE. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9749536 ↗
• MalfunctionFeb 18, 2020Material Frayed; Material Frayed

  STRYKER LEG HOLDER HAS ABRASION ON THE TOP OF THE LEG HOLDER AND THE HOSPITAL IS NO LONGER ABLE TO STERILIZE IT PROPERLY AND SPD REQUESTS A REPLACEMENT. CASE TYPE: NO ASSOCIATED PROCEDURE. UPDATE: AS PER CLOSED DUPLICATE (B)(4): "AS REPORTED: "HOSPITAL REQUESTED A REPLACEMENT MAKO KNEE HOLDER BOOT DUE TO DAMAGE. IT IS CHIPPED/ DELAMINATED." SPOKE TO REP. NO. ASSOCIATED PROCEDURE. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.'.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9722480 ↗
• MalfunctionFeb 11, 2020Material Frayed; Sharp Edges; Material Frayed; Sharp Edges

  WAS ASKED BACK TO SPD TO GRAB THE BAR EXTENSION AND THE BOOT (BOTH CARBON FIBER PIECES) FROM THE CLEAN SIDE OF SPD BECAUSE A HOSPITAL ASSOCIATE WAS CHECKING BOTH ITEMS FOR CLEANLINESS AND GOT SPLINTERS FROM THE BOOT AND EXTENSION. THE BOOT IS VISIBLY FRAYED AT THE DISTAL END AND THE BAR EXTENSION, THE ASSOCIATE TOLD ME SHE GOT THEM ALSO FROM THE DISTAL END. SPD MANAGER HAS ASKED ME TO REPLACE BOTH OF THESE SO THAT FUTURE SPD STAFF DO NOT GET INJURED DUE TO SPLINTERING. ZERO ISSUES BEFORE, DURING, OR IMMEDIATELY AFTER A CASE SO I AM NOT TREATING THIS AS A CASE ISSUE. CASE TYPE: N/A SPD STAFF GOT CARBON FIBER SPLINTERS. WAS REPORTED IN THEIR OWN FACILITY. SPD MANAGER ASKED THAT I SIMPLY GET THEM REPLACED, THE INJURY IS VERY MINOR AND HAS BEEN ADDRESSED INTERNALLY. NO PICTURES TAKEN OF THE DAMAGE TO THESE PIECES.

  Patient problems: No Patient Involvement; Tissue Damage

  MAUDE report 9696039 ↗
• MalfunctionFeb 11, 2020Fracture; Material Frayed; Sharp Edges; Fracture; Material Frayed; Sharp Edges

  A SMALL PIECE OF THE BOOT ASSEMBLY HAS CRACKED OFF CREATING A SHARP EDGE ON THE CARBON FIBER. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9694884 ↗
• MalfunctionFeb 4, 2020Crack; Fracture; Crack; Fracture

  TKA BOOT CRACKED. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9663321 ↗
• MalfunctionFeb 4, 2020Crack; Material Frayed; Crack; Material Frayed

  CPD ALERTED OUR JR REP ABOUT CRACKING AND DELAMINATION OF THE BLACK LEG HOLDER. THERE IS CONCERN FOR FURTHER CRACKING AND POSSIBLE PATIENT/STAFF HARM WHEN IN USE. WOULD LIKE TO REPLACE THE PART. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9663233 ↗
• MalfunctionJan 30, 2020Crack; Crack

  THERE IS A CHIP/CRACK IN THE BOOT AND IS BEGINNING TO PEEL. NOT SURE WHEN IT OCCURRED, BUT WAS NOTICED WHEN TRAY WAS OPENED. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9646690 ↗
• MalfunctionJan 30, 2020Crack; Crack

  SPD NOTIFIED ME OF A CRACK IN THE CARBON FIBER BOOT. THE CRACK IS ALL THE WAY THROUGH THE CARBON FIBER. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9646683 ↗
• MalfunctionJan 30, 2020Material Frayed; Material Frayed

  DURING JOINT ASSESSMENT OF SURGERY, SURGEON NOTICED THAT CARBON FIBERS ON THE BOOT APPEARED TO BE FRAYED. FRAYED AREA IS NOTICEABLE AT THE TOP PORTION OF THE BOOT NEAR THE CALF. NO ADVERSE CONSEQUENCES. PLEASE REPLACE BOOT AS SOON AS POSSIBLE. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9646676 ↗
• MalfunctionJan 20, 2020Crack; Crack

  BLACK BOOT BEGINNING TO CRACK AT FOOTPLATE AND UPPER CALF AREA, COULD LEAD TO SPLINTERING AND FURTHER DAMAGE. CPD ALERTED ME OF THIS AND WOULD LIKE IT REPLACED. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9607708 ↗
• MalfunctionJan 19, 2020Crack; Crack

  BOOT IS CRACKED/CHIPPED AND COULD CAUSE STERILITY PROBLEMS. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9604848 ↗
• MalfunctionJan 17, 2020Crack; Fracture; Crack; Fracture

  BOOT IS CHIPPED/CRACKED AROUND PROXIMAL PORTION. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9603378 ↗
• MalfunctionJan 13, 2020Degraded; Material Frayed; Degraded; Material Frayed

  BOOT STARTING TO FRAY AND CAUSE LOOSE SHAVINGS. CASE TYPE: TKA. PATIENT UNDER ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9583881 ↗