NA 144140Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00848486018177), received between Jun 11, 2018 and Dec 1, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Positioning Failure; Insufficient Device Problem Information; Positioning Failure; Insufficient Device Problem Information

  NO NEW INFORMATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Anemia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 23680481 ↗
• InjuryJan 6, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  A FRACTURE OCCURRED IN THE ILIAC CREST OF THE HEALTHY LEG WHERE THE ANCHORING PIN WAS PLACED.

  Patient problems: Bone Fracture(s)

  MAUDE report 21082755 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE OF MY SURGEONS TOLD ME THAT ONE OF HIS PATIENTS HAD A FEMORAL FRACTURE NEAR THE SITE OF A PIN PLACED FOR A PRIMARY MAKO KNEE. THE FRACTURE DID NOT OCCUR INTRAOPERATIVELY. THE SURGEON SAID THE POST OP X-RAY SHOWED NO FRACTURE. THE PATIENT REPORTED ROLLING OVER IN BED, FEELING A "POP", AND GOING INTO THE ER TO FIND SHE HAD A FRACTURED FEMUR. CASE TYPE/PROCEDURE: LEFT TKA. PER RESPONSE: "THE CASE WAS A TKA. NO REVISION WAS DONE. THE FEMUR WAS REDUCED AND PLATED BY ANOTHER SURGEON."

  Patient problems: Bone Fracture(s)

  MAUDE report 16342552 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE OF MY SURGEONS TOLD ME THAT ONE OF HIS PATIENTS HAD A FEMORAL FRACTURE NEAR THE SITE OF A PIN PLACED FOR A PRIMARY MAKO KNEE. THE FRACTURE DID NOT OCCUR INTRAOPERATIVELY. THE SURGEON SAID THE POST OP X-RAY SHOWED NO FRACTURE. THE PATIENT REPORTED ROLLING OVER IN BED, FEELING A "POP," AND GOING INTO THE ER TO FIND SHE HAD A FRACTURED FEMUR. CASE TYPE/PROCEDURE: LEFT TKA. PER RESPONSE: "THE CASE WAS A TKA. NO REVISION WAS DONE. THE FEMUR WAS REDUCED AND PLATED BY ANOTHER SURGEON."

  Patient problems: Bone Fracture(s)

  MAUDE report 16342509 ↗
• InjuryMay 8, 2019Material Integrity Problem; Material Integrity Problem

  SUPRACONDYLAR FRACTURE OF FEMUR AT OR NEAR PIN LOCATION AT 6 WEEKS POST-OP. CASE TYPE: TKA.

  Patient problems: Bone Fracture(s)

  MAUDE report 8593687 ↗
• MalfunctionApr 23, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  SURGEON WAS REMOVING FEMORAL PINS AFTER COMPLETING MAKO PORTION OF THE TOTAL KNEE REPLACEMENT AND THE FEMORAL DISTAL PIN SNAPPED WHILE BEING PULLED OUT. CASE TYPE: TKA. SURGICAL DELAY: =15 MINUTES. DID THE EVENT OCCUR DURING THE CASE? AS PER THE MPS: YES, THE EVENT OCCURRED DURING THE CASE. WE HAD JUST OPENED FINAL IMPLANTS BUT HAD NOT IMPACTED YET. WAS THE PATIENT UNDER ANESTHESIA? YES. WERE ANY DEBRIS/COMPONENTS LEFT INSIDE OF THE PATIENT? (YES/NO) AS PER THE MPS: YES, A PIECE OF THE PIN WAS LEFT INSIDE THE BONE. THE SURGERY WAS PAUSED AND AN X-RAY WAS TAKEN. THE SURGEON DECIDED TO LEAVE THE PIECE OF PIN INSIDE OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8540296 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information; Non Reproducible Results; Insufficient Device Problem Information; Non Reproducible Results

  AS REPORTED: CONVERSATION WITH DR. (B)(6) ABOUT HAVING ISSUES WITH THE 4X140 AND 4X170 PINS CRACKING THE FEMORAL CORTEX WHEN BEING DRILLED IN FOR ARRAY PLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7586291 ↗