NA 210110Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00848486031848), received between Aug 15, 2018 and Jun 15, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2023Mechanical Problem; Mechanical Problem

  THE BLUE HANDLE WOULD NOT TIGHTEN CAUSING THE LEG TO BE UNSTABLE CASE TYPE / APPLICATION: TKA. PER RESPONSE: "THE BLUE KNOB WOULD NOT TIGHTEN, AND THE PATIENT'S LEG EXTERNALLY ROTATED OFF THE TABLE." ADDITIONAL INFORMATION 6/27/2023: DID THE PATIENT¿S LEG FALL OFF THE TABLE? NO, THE BLUE KNOB WAS NOT TIGHTENING DOWN WHICH ALLOWED THE LEG TO BE UNSTABLE AND ROTATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140224 ↗
• MalfunctionNov 12, 2020Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  SETTING UP FOR A MAKO PKA CASE, DR WAS ASSEMBLING THE MAKO LEG POSITIONER ONTO THE BED AND PATIENT LEG. WHEN DR PLACED THE BOOT & PATIENT LEG INTO THE SLED- THE LEG POSITIONER SLED WOULD NOT HOLD THE WEIGHT OF THE LEG IN POSITION. THE LEG WOULD KEEP FALLING LATERAL WHENEVER THE LEG WAS LET GO BY THE SURGEON. NO DELAYS TO SURGERY, SURGERY WAS COMPLETED BY ASSISTANT MANUALLY HOLDING THE LEG IN PLACE TO SUPPORT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10828809 ↗
• MalfunctionJan 10, 2020Crack; Material Frayed; Sharp Edges; Crack; Material Frayed; Sharp Edges

  STRYKER MAKO LEG HOLDERS. NUMEROUS PIECES HAVE EXPOSED FIBERS, TWO PIECES HAVE STRESS FRACTURES AT THE POINT WHERE THE METAL FITTING IS INSERTED. REPORT OF "SOMEONE GETTING STUCK" BY AN EXPOSED FIBER. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA. UPDATE : HOW MANY SURGERIES WERE INVOLVED WITH THE REPORTED ISSUE? APPROXIMATELY 300 PROCEDURES TO GET TO THIS POINT. ALL THE REPORTED DEVICES THAT ARE INCLUDED IN THIS COMPLAINT WERE FOR ONE OR MANY SURGERIES? MANY ¿ SPD CALLED US CONCERNED ABOUT EXPOSED FIBERS AND CRACKS. HAVE YOU REPORTED EACH INCIDENT SEPARATELY THAT HAS THE ISSUES YOU HAVE MENTIONED IN THIS COMPLAINT? (IF NO, PLEASE SUBMIT A COMPLAINT FOR EACH ISSUE.) NO ¿ MULTIPLE LEG HOLDERS ARE EXHIBITING WEAR. THE ITEMS LISTED IN THE PER EITHER HAVE EXPOSED FIBERS OR CRACKS. PLEASE CONFIRM IF THERE WAS A PATIENT THAT WAS ¿STUCK¿ BY THE EXPOSED CARBON FIBER? NOT A PATIENT ¿ A STAFF MEMBER.

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

  MAUDE report 9577650 ↗
• MalfunctionJan 10, 2020Crack; Material Frayed; Sharp Edges; Crack; Material Frayed; Sharp Edges

  STRYKER MAKO LEG HOLDERS. NUMEROUS PIECES HAVE EXPOSED FIBERS, TWO PIECES HAVE STRESS FRACTURES AT THE POINT WHERE THE METAL FITTING IS INSERTED. REPORT OF "SOMEONE GETTING STUCK" BY AN EXPOSED FIBER. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA. UPDATE : HOW MANY SURGERIES WERE INVOLVED WITH THE REPORTED ISSUE? APPROXIMATELY 300 PROCEDURES TO GET TO THIS POINT. ALL THE REPORTED DEVICES THAT ARE INCLUDED IN THIS COMPLAINT WERE FOR ONE OR MANY SURGERIES? MANY ¿ SPD CALLED US CONCERNED ABOUT EXPOSED FIBERS AND CRACKS. HAVE YOU REPORTED EACH INCIDENT SEPARATELY THAT HAS THE ISSUES YOU HAVE MENTIONED IN THIS COMPLAINT? (IF NO, PLEASE SUBMIT A COMPLAINT FOR EACH ISSUE.) NO ¿ MULTIPLE LEG HOLDERS ARE EXHIBITING WEAR. THE ITEMS LISTED IN THE PER EITHER HAVE EXPOSED FIBERS OR CRACKS. PLEASE CONFIRM IF THERE WAS A PATIENT THAT WAS ¿STUCK¿ BY THE EXPOSED CARBON FIBER? NOT A PATIENT ¿ A STAFF MEMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9577644 ↗
• MalfunctionAug 24, 2018Mechanical Problem; Mechanical Problem

  LEG KEPT FALLING TO THE SIDE WHILE LOCKED INTO PLACE. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812814 ↗
• MalfunctionAug 15, 2018Mechanical Problem; Non Reproducible Results; Mechanical Problem; Non Reproducible Results

  SLED WOULD NOT TIGHTEN ENOUGH TO KEEP LEG UPRIGHT. LEG KEEP FALLING EITHER INTERNAL OR EXTERNAL. SURGICAL DELAY YES -16-30 MINUTES; CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7786656 ↗