NA 210070Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00848486031862), received between Mar 19, 2019 and Jan 10, 2020 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 9577345 ↗
• 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 9577344 ↗
• MalfunctionDec 23, 2019Fracture; Fracture

  CPD FOUND PUTTING AND CRACKING ALONG THE EXTENSION BAR TO THE BACK LEG HOLDER. THERE IS CONCERN THAT SPLINTERING COULD CONTINUE AND CAUSE HARM TO PATIENT OR STAFF WHILE IN USE. THE HOSPITAL WOULD LIKE THE PIECE REPLACED. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9513177 ↗
• MalfunctionOct 1, 2019Material Frayed; Material Integrity Problem; Material Frayed; Material Integrity Problem

  SPLINTERING IN THE BLACK LEG HOLDER HAS OCCURRED AND GAVE EMPLOYEE IN CPD SPLINTERS (CARBON FIBER) THAT HAS CAUSED CONCERN AS TO THE STRUCTURAL INTEGRITY OF THE DEVICE AND IF FURTHER SPLINTERING COULD OCCUR IN THE OR AND AFFECT THE PATIENT. WOULD LIKE ALL CARBON PIECES REPLACED (CREATING INDIVIDUAL COMPLAINTS PER PIECE). CASE TYPE: (B)(4). PATIENT WAS UNDER ANESTHESIA.

  Patient problems: Tissue Damage

  MAUDE report 9141691 ↗
• MalfunctionSep 9, 2019Material Integrity Problem; Material Integrity Problem

  CARBON FIBERS ARE STICKING OUT. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974447 ↗
• MalfunctionMay 31, 2019Material Integrity Problem; Material Integrity Problem

  CARBON RAIL EXTENSION PIECE CHIPPING ALONG EDGES. CASE TYPE: TKA. UPDATE: PATIENT WAS NOT UNDER ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8658751 ↗
• MalfunctionMay 16, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  SCRUB TECH NOTICED SPLINTERING OF CARBON FIBER, ON BASE AND EXTENSION, WHILE INSTALLING THEM. CASE TYPE: TKA UPDATE: "YES. PATIENT WAS UNDER ANESTHESIA."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8617553 ↗
• MalfunctionMar 25, 2019Break; Mechanical Problem; Break; Mechanical Problem

  WE WERE IN THE MIDDLE OF OUR TKA CASE. DR. (B)(6) WAS USING THE STRYKER LEG HOLDER. HE PUT THE LEG INTO EXTENSION, (THE PT WAS TALL WITH A LONG LEG), AS HE PUT THE LEG INTO EXTENSION THE EXTENSION BAR ON THE LEG HOLDER FELL APPART. THE CARBON FIBER PIECE FELL OFF OF THE METAL ATTACHMENT PIECE THAT SNAPS INTO THE BASE BAR. CASE TYPE: TKA. SURGICAL DELAY: =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8449573 ↗
• MalfunctionMar 19, 2019Material Integrity Problem; Material Integrity Problem

  THE BAR EXTENSION ASSEMBLY HAS EXPOSED CARBON FIBERS . CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8431859 ↗
• MalfunctionMar 19, 2019Material Integrity Problem; Material Integrity Problem

  THE BAR EXTENSION ASSEMBLY HAS EXPOSED CARBON FIBERS. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8431851 ↗
• MalfunctionMar 19, 2019Material Integrity Problem; Material Integrity Problem

  THE BAR EXTENSION ASSEMBLY IN THE NEW STRYKER LEG HOLDER HAD EXPOSED CARBON FIBERS WHEN REMOVED FROM PACKAGE. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8431797 ↗
• MalfunctionMar 19, 2019Material Integrity Problem; Material Integrity Problem

  THE BAR EXTENSION ASSEMBLY HAS EXPOSED CARBON FIBERS CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8431796 ↗