NA 213527Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327412376), received between Oct 31, 2019 and Jan 12, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: POSTOPERATIVE RADIOGRAPH OF MAKOTKA REVEALED A FRACTURED TIP OF THE 3.2MM X 140MM BONE PIN INSERTED INTO THE FEMUR, WITH THE BROKEN FRAGMENT REMAINING IN PLACE. AS A CORRECTIVE MEASURE, THE PIN INSERTION SITE WAS REOPENED, THE PIN WAS REMOVED, AND THE WOUND WAS CLOSED.

  Patient problems: Insufficient Information

  MAUDE report 24040930 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MAKO TKA FOR RIGHT KNEE WAS PERFORMED ON (B)(6) 2024. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 BECAUSE THE FRACTURE OF THE FEMORAL SHAFT OCCURRED AT THE FEMORAL PIN INSERTION SITE. THE CAUSAL RELATIONSHIP AND WHEN THE FRACTURE OCCURRED ARE UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20272862 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MAKO TKA FOR RIGHT KNEE WAS PERFORMED ON (B)(6) 2024. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 BECAUSE THE FRACTURE OF THE FEMORAL SHAFT OCCURRED AT THE FEMORAL PIN INSERTION SITE. THE CAUSAL RELATIONSHIP AND WHEN THE FRACTURE OCCURRED ARE UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20272716 ↗
• InjuryDec 20, 2023Fracture; Fracture

  THE FEMUR BONE PIN WAS BROKEN DURING SURGERY USING MAKO SYSTEM. THE DOCTOR MADE AN INCISION WITH A SCALPEL TO REMOVE THE BROKEN PIN FROM THE PATIENT'S BODY. THE BONE PIN WAS DISCARDED IMMEDIATELY AFTER REMOVAL AND THE SURGERY COMPLETED WITHOUT PROBLEM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369994 ↗
• InjuryOct 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020, THE PATIENT UNDERWENT TKA (LEFT) FOR KNEE JOINT. POSTOPERATIVE FRACTURE OCCURRED FROM THE POSITION OF THE PIN INSERTION FOR FEMORAL ARRAY INSTALLATION. SO, THE PATIENT UNDER WENT REVISION ON (B)(6) 2020.

  Patient problems: Bone Fracture(s)

  MAUDE report 10740218 ↗
• MalfunctionFeb 26, 2020Fracture; Fracture

  SURGEON BEGAN PLACING PIN IN HIP FOR ARRAY PLACEMENT (NON OPERATIVE HIP FOR DA APPROACH). SURGEONS STATED HE BARELY BROKE BIN WHEN THE TIP BROKE OFF. PATIENT WAS X-RAYED AND TIP OF PIN WAS REMOVED FROM THE BONE. CASE TYPE: THA.

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

  MAUDE report 9757994 ↗
• MalfunctionDec 23, 2019Fracture; Fracture

  TWO OF THE 3.2MM X 140MM BONE PINS SNAPPED OFF INSIDE PATIENT WHILE DRILLING. APPROX. 1CM OF THE THREADED PART OF THE PIN SNAPPED OFF THE FIRST, APPROXIMATELY 4MM OF THE SECOND. FIRST PIN SNAPPED ON I SECTION, 2ND SNAPPED ON EXTRACTION. CASE TYPE: TKA. 16-30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9512808 ↗
• MalfunctionOct 31, 2019Break; Fracture; Break; Fracture

  3.2 X 140 PIN BROKE IN HALF WHEN DR. WAS REMOVING THE PIN. CASE TYPE: TKA. UPDATE: PIN WAS BEING REMOVED FROM FEMUR WHEN IT BROKE. IT WAS IN THE FEMORAL ARRAY STABILIZER. BOTH HALVES OF BONE PIN REMOVED.

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

  MAUDE report 9260623 ↗