NA 206967Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00848486022167), received between Nov 14, 2018 and Aug 21, 2025 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 9, 2020Terminated

   Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

   Z-2745-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Material Fragmentation; Residue After Decontamination; Material Fragmentation; Residue After Decontamination

  NO NEW INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858984 ↗
• MalfunctionJul 1, 2025Material Fragmentation; Material Fragmentation

  A VISUAL INSPECTION WAS PERFORMED AND DARK GRAY PARTICLES WERE DETECTED INSIDE THE HIP END EFFECTOR. THE PARTICLES ARE APPARENTLY GENERATED BY THE ROTARY MOVEMENT OF THE INSTRUMENTS. IT IS RECOMMENDED TO REPLACE THESE INSTRUMENTS UNTIL THE END OF THE INVESTIGATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373917 ↗
• MalfunctionJun 27, 2025Material Fragmentation; Residue After Decontamination; Material Fragmentation; Residue After Decontamination

  DARK GRAY PARTICLES WERE FOUND INSIDE HIP END EFFECTOR AFTER SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343575 ↗
• MalfunctionJun 24, 2025Material Fragmentation; Residue After Decontamination; Material Fragmentation; Residue After Decontamination

  DARK GRAY PARTICLES WERE FOUND INSIDE THE HIP END EFFECTOR AFTER SURGICAL PROCEDURE USING MAKO ROBOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313558 ↗
• MalfunctionJun 11, 2025Material Fragmentation; Material Fragmentation

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22188111 ↗
• MalfunctionDec 15, 2020Failure to Calibrate; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Adverse Event Without Identified Device or Use Problem

  HIP EE IS PART OF A RECALL.. CASE TYPE / APPLICATION: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012675 ↗
• InjuryAug 28, 2020Difficult to Insert; Difficult to Insert

  THE EVENT OCCURRED DURING THE THA (RIGHT) PROCEDURE. AT THE TIME OF PRE-OPERATIVE SETTING, THE ANGLE OF THE OFFSET REAMER WAS SET TO 45° TO THE RIGHT ACCORDING TO THE MANUAL, BUT WHEN THE REAMER WAS PUT INTO THE WOUND, THE OFFSET DID NOT MATCH AND WAS CHANGED BY THE SURGEON HIMSELF. WHEN THE MSP CHECKED THE ANGLE WITH THE SURGEON, THE SURGEON RESPONSE WAS 90°, SO THE ANGLE WAS CHANGED TO 90°. AFTER THAT, HE WAS RELUCTANT TO REAM, BUT JUDGED THAT THE REAMER WAS BEING FLIPPED BECAUSE THE CENTER DID NOT FIT AND HE CONTINUED TO REAM. AFTER REAMING, THE POSITION WAS VISUALLY INSPECTED AND IT WAS POINTED OUT THAT THE CUTTING POSITION WAS INCORRECT, AND IT WAS SUSPECTED THAT THE PELVIC ARRAY HAD MOVED, AND THE REGISTRATION ACCURACY WAS CONFIRMED ON THE CT VIEW. WHEN THE INSIDE OF THE ACETABULUM WAS CHECKED WITH A POINTER, THERE WAS NO PROBLEM IN THE POSITION, BUT IT SEEMS THAT THERE WAS A DEVIATION IN THE DEPTH, AND ALTHOUGH THE UPPER ANTERIOR ILIAC SPINES ON BOTH SIDES WERE CONFIRMED, THERE WAS NO DEVIATION AND THERE WAS A PROBLEM WITH REGISTRATION ACCURACY. NEXT, WHEN THE REPORTING SR SUSPICIOUSLY CONFIRMED THAT THE ANGLE OF THE OFFSET HANDLE WAS SET INCORRECTLY, THE ANGLE ON THE REAMER

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

  MAUDE report 10468764 ↗
• MalfunctionJan 28, 2020Fracture; Fracture

  END EFFECTOR BROKEN- PRODUCING METAL SHAVINGS WHEN IMPACTING. HIGH VOLUME ACCOUNT. PLEASE SEND REPLACEMENT ASAP. THANKS! CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9640106 ↗
• MalfunctionDec 23, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  WHEN BREAKING DOWN THE ROBOT THE BACK PART OF THE END EFFECTOR BROKE OFF AND SEPARATED. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9512802 ↗
• MalfunctionDec 11, 2019Break; Fracture; Detachment of Device or Device Component; Material Integrity Problem; Break; Fracture; Detachment of Device or Device Component; Material Integrity Problem

  REAR LOCKING MECHANISM BROKEN OFF AT THE THREADS. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9452834 ↗
• MalfunctionDec 11, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THE DISK ON THE BACK OF THE ADAPTER BROKE OFF AND WILL NOT THREAD ON. CASE TYPE: THA THE PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9452833 ↗
• MalfunctionDec 10, 2019Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  NOTICED BROKEN PIECE WHILE TAKING OFF END EFFECTOR AT END OF CASE.CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9445993 ↗
• MalfunctionDec 2, 2019Fracture; Fracture

  INTERNAL RING BROKE DURING IMPACTION, NEED REPLACEMENT ASAP CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9397102 ↗
• MalfunctionDec 2, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  STUB ON BOTTOM OF THA END EFFECTOR ARRAY CAME OFF AFTER REMOVAL FROM MAKO ARM (AFTER CASE). CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9396699 ↗
• MalfunctionNov 22, 2019Fracture; Fracture

  END EFFECTOR COLLAR BROKE OFF. CASE TYPE: THA. PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9362260 ↗
• MalfunctionNov 15, 2019Break; Fracture; Detachment of Device or Device Component; Material Integrity Problem; Break; Fracture; Detachment of Device or Device Component; Material Integrity Problem

  BACK END OF THE END EFFECTOR BROKE OFF DURING REAMING. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9327523 ↗
• MalfunctionNov 8, 2019Break; Break

  AFTER IMPACTING THE PROSTHESIS, THE SURGICAL NURSE NOTICED THAT A BALL BEARING OF THE HIP END EFFECTOR WAS LYING ON THE FLOOR. IN ORDER TO EXCLUDE THAT FURTHER METAL PARTS REMAINED IN THE PATIENT, AN ADDITIONAL X-RAY PICTURE WAS MADE. NO REPLACEMENT DEVICE WAS USED. UPDATE: "5 MINUTES SURGICAL DELAY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9299108 ↗
• MalfunctionOct 2, 2019Crack; Material Integrity Problem; Crack; Material Integrity Problem

  HIP END EFFECTOR WAS DAMAGED WHILE SURGEON WAS IMPACTING CUP. IMPACTOR PLATE AND INLINE OFFSET IMPACTOR WERE DAMAGED AS WELL. I HAD A REPLACEMENT SET OF INSTRUMENTS TO OPEN ONTO THE STERILE FIELD. SURGEON HAD DIFFICULTY REMOVING BROKEN INSTRUMENTS OFF OF THE ROBOT, WHICH ADDED TO THE DELAY IN SURGERY. CASE TYPE: THA. SURGICAL DELAY: 35 MINUTES. THIS COMPLAINT IS FOR THE 206967 HIP END EFFECTOR, VARIABLE ANGLE. ASSOCIATED COMPLAINTS FROM THE SAME SURGERY INCLUDE: (B)(4).

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

  MAUDE report 9147809 ↗
• MalfunctionSep 6, 2019Break; Break

  (B)(6) (MPS) REPORTED THAT: "BROKEN INNER MESH THAT CAUSES AN ERROR OF 0.5 MM WHEN REGISTERING THE ROBOT" DELAY : 10MIN UPDATE: WAS PATIENT IN THE OPERATING ROOM AT THE TIME OF DISCOVERY? YES. WAS PATIENT UNDER ANESTHESIA? YES. WAS SURGICAL PROCEDURE COMPLETED SUCCESSFULLY? YES. CASE TYPE: THA.

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

  MAUDE report 8970606 ↗
• MalfunctionSep 3, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  REAMER SHAFT LOCKING MECHANISM BROKEN DURING IMPACTION. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8955597 ↗
• MalfunctionJul 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AT THE END OF THE CASE, FOUND OUT THAT THE COLLAR OF THE HANDPIECE BROKE OFF. CASE TYPE: THA. UPDATE: THE COLLAR AT THE END OF END EFFECTOR BROKE OFF. UPDATE: NO DEBRIS LEFT IN PATIENT & NOTHING MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8828204 ↗
• MalfunctionJul 8, 2019Fracture; Mechanical Problem; Fracture; Mechanical Problem

  AFTER REAMING, THE SCRUB TECH WAS COULD NOT REMOVE THE REAMING HANDLE FROM THE END EFFECTOR. UPON FURTHER INSPECTION, THE SURGEON NOTICED THERE WAS WHAT LOOKED LIKE A PIECE OF PLASTIC STICKING OUT FROM THE SIDE OF THE END EFFECTOR. HE USED AN INSTRUMENT TO REMOVE IT ALONG WITH A THIN SILVER RING, BOTH IN PHOTOS. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8769330 ↗
• MalfunctionApr 16, 2019Fracture; Non Reproducible Results; Fracture; Non Reproducible Results

  THE COLLET SLEEVE ON THE END EFFECTOR CANE APART. THE MECHANISM INSIDE BROKE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8517745 ↗
• MalfunctionFeb 21, 2019Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  POST-IMPACTION SURGICAL TEAM FOUND A PIECE OF METAL NEAR THE WOUND AND WE DISCOVERED IT HAD BROKEN OFF THE END EFFECTOR. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8358267 ↗
• MalfunctionJan 7, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  THE HIP END EFFECTOR BROKE DURING THE IMPACTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8222244 ↗