NA 111645Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00848486029494), received between Oct 31, 2018 and Jan 12, 2026 — classified as 6 injuries, 6 malfunctions.

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

• MalfunctionJan 12, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: CLINICAL EVENT INFORMATION: THEY WERE DOING A MAKO TOTAL HIP REPLACEMENT WHEN THE ORTHOPAEDIC REG WAS REMOVING THE ACETABULUM CHECKPOINT PIN THE HEAD OF THE PIN BROKE OFF FROM THE PIN. LEAVING THE TIP OF IT RETAINED IN THE PATIENT. THE SURGEON AND REGISTRAR TRIED TO RETRIEVE IT, BUT IT WAS BURIED IN THE BONE. X-RAY COMPLETED TO CONFIRM LOCATION. THEY WERE DOING A MAKO TOTAL HIP REPLACEMENT WHEN THE ORTHOPAEDIC REG WAS REMOVING THE ACETABULUM CHECKPOINT PIN THE HEAD OF THE PIN BROKE OFF FROM THE PIN. LEAVING THE TIP OF IT RETAINED IN THE PATIENT. THE SURGEON AND REGISTRAR TRIED TO RETRIEVE IT, BUT IT WAS BURIED IN THE BONE. X-RAY COMPLETED TO CONFIRM LOCATION. THEATRE COORDINATOR INFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040235 ↗
• MalfunctionMar 31, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  TIBIAL CHECKPOINT BROKE OFF IN PATIENT WHEN BEING REMOVED. HALF REMAINS IN PATIENT. ADDITIONAL INFORMATION PROVIDED: PART OF THE CHECKPOINT REMAINS WITHIN THE PATIENT¿S TIBIA. I AM NOT AWARE OF ANY ADVERSE CONSEQUENCES. SURGEON HAS NO PLANS TO REMOVE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729899 ↗
• InjuryAug 18, 2021Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  CHECKPOINTS LEFT IN PATIENT. PATIENT NEEDED SECONDARY SURGERY TO REMOVE CHECKPOINTS, AND PERFORM LINER EXCHANGE. UPDATE: THE SURGEON INFORMED ME A FEW DAYS AFTER THE PRIMARY SURGERY THAT WE HAD LEFT HARDWARE IN BUT IF NO INTERVENTION WAS NECESSARY, WE WOULD LEAVE IT. THE PATIENT'S KNEE BECAME SWOLLEN AND INFECTED, SO WE WENT BACK IN FOR A HARDWARE REMOVAL AND LINER EXCHANGE. AT THAT POINT I CONSIDERED THE CASE TO BE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 12335839 ↗
• MalfunctionDec 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  TIBIAL AND FEMORAL CHECKPOINTS WERE LEFT IN PATIENT AFTER TKA PROCEDURE. CASE TYPE: TKA. UPDATE: HOW MANY TIBIAL CHECKPOINTS WERE LEFT IN THE PATIENT? 1. HOW MANY FEMORAL CHECKPOINTS WERE LEFT IN THE PATIENT? 1. DID THE CHECKPOINTS BREAK AND PARTIAL PIECES WERE LEFT IN THE PATIENT? NO, CHECKPOINTS DID NOT BREAK. ENTIRE CHECKPOINTS WERE LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9451595 ↗
• InjuryDec 2, 2019Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER RIGHT MAKO KNEE IMPLANTATION ON (B)(6) 2019, POST-OP X-RAYS REVEALED THE FEMORAL CHECKPOINT WAS IN THE PATIENT. ON (B)(6) 2019, PATIENT UNDERWENT SURGERY TO REMOVE THE CHECKPOINT. THE REP WHO REPORTED THE NOVEMBER SURGERY WAS NOT PRESENT FOR EITHER PROCEDURE, BUT TWO MPS'S WERE PRESENT FOR THE OCTOBER PROCEDURE. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Tissue Damage

  MAUDE report 9394852 ↗
• MalfunctionOct 15, 2019Break; Device Slipped; Break; Device Slipped

  AT (B)(6) HOSPITAL WITH (B)(6), WHILE REMOVING TIBIAL CHECKPOINT FOLLOWING A MAKO TKA THE TIP OF THE CHECKPOINT BROKE OFF INTO THE PATIENTS CORTICAL BONE. APPROXIMATELY 3-5 MM REMAINS IN SITU IN THE PATIENTS TIBIAL TUBEROSITY. RIGHT MAKO TRIATHLON TIP OF THE TIBIAL CHECKPOINT REMAINS IN THE PATIENTS BONE.

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

  MAUDE report 9191238 ↗
• MalfunctionMay 28, 2019Improper or Incorrect Procedure or Method; Non Reproducible Results; Improper or Incorrect Procedure or Method; Non Reproducible Results

  THE SURGEON TEXTED ME IN THE EVENING AFTER THE SURGERY. HE SAID THAT THE CHECK POINTS HAD BEEN LEFT IN THE PATIENT. I RESPONDED THAT MY PRACTICE WAS ALWAYS TO REMIND THE OPERATIVE STAFF TO REMOVE CHECKPOINTS. THE FOLLOWING DAY, THE SURGEON TOLD ME THAT HE HAD DECIDED TO LEAVE THE CHECKPOINTS IN THE PATIENT AND ONLY REMOVE THEM IF THERE WAS A PROBLEM. HE SAID THE PATIENT WAS NOT UPSET ABOUT IT AND THE SURGEON DIDN'T BLAME ME FOR THE INCIDENT. THE HOSPITAL ORTHOPEDIC COORDINATOR TOLD THE SURGEON THAT THE CHECKPOINTS WERE DEFINITELY PART OF THE OFFICIAL COUNT, SO THE NURSE AND TECH IN THE ROOM SHOULD HAVE CAUGHT IT, AS WELL AS THE PHYSICIAN'S ASSISTANT AND SURGEON. THERE HAVE BEEN NO REPERCUSSIONS FROM ANY PARTY FOR THIS INCIDENT TO DATE. CASE TYPE: PKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8645337 ↗
• InjuryMay 2, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  DURING THE CEMENTING OF THE FINAL IMPLANTS, DR. (B)(6) SUSPECTED A POTENTIAL FRACTURE IN THE TIBIA. HE MADE A COMMENT ABOUT THE BLUE TIP BREAKING OFF OF THE TIBIAL BASEPLATE IMPACTOR WHILE HE WAS SLIDING THE IMPACTOR FROM THE POSTERIOR PART OF THE BASEPLATE TO ANTERIOR AND THAT SOME OF THE FINAL IMPACTIONS MAY HAVE BEEN METAL ON METAL. HE PUT IN THE FEMORAL AND INSERT TRIALS AND PLACED THE LEG IN EXTENSION WITH AN AXIAL LOAD TO FULLY SEAT THE CEMENTED TIBIA BASEPLATE RATHER THAN CONTINUE TO USE AN IMPACTOR. HE NOTICED THE TIBIAL CHECKPOINT SEEMED LOOSE AND WAS EASILY ABLE TO PULL IT OUT. ONCE REMOVED, HE WAS ABLE TO CONFIRM THERE WAS A FRACTURE AND ORDERED AN X-RAY. AN X-RAY CONFIRMED A FRACTURE FROM THE TIBIA PLATEAU EXTENDING TO WHERE THE POSITION OF THE TIBIA CHECKPOINT WAS SEATED. DR. HAAS SUSPECTS THE FRACTURE PROPAGATED AT THE TIBIAL KEEL AND WORKED ITS WAY ANTERIOR TO THE LATERAL SIDE OF THE PEG AND DOWN TO THE CHECKPOINT, ALTHOUGH HE WAS NOT ABLE TO CONFIRM IT WENT TO THE KEEL BECAUSE THE IMPLANT WAS ALREADY CEMENTED DOWN. DR. (B)(6), A TRAUMA SURGEON, WAS CALLED IN TO REPAIR THE FRACTURE. FOLLOWING THIS, ALIGNMENT WAS CHECKED IN KINEMATIC ANALYSIS AS WELL AS WALKING THE GR

  Patient problems: Bone Fracture(s)

  MAUDE report 8574156 ↗
• InjuryMar 21, 2019Use of Device Problem; Non Reproducible Results; Use of Device Problem; Non Reproducible Results

  AFTER COMPLETION OF CASE, THE NURSE COUNT OF CHECKPOINTS WAS COMPLETED SAYING THAT ALL CHECKPOINTS AND SPONGES WERE OUT. UNFORTUNATELY UPON POST-OP X-RAY, IT WAS DISCOVERED THAT BOTH FEMORAL AND TIBIAL CHECKPOINTS WERE STILL IN PATIENT. PATIENT WAS CALLED BACK THE NEXT DAY TO HAVE THEM REMOVED BY DR. (B)(6). CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8440073 ↗
• MalfunctionFeb 5, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  FEMUR CHECKPOINT BROKE WHILE BEING REMOVED WITH PLIERS. HALF IS STILL IN THE PATIENT , THE OTHER HALF WAS TAKEN BY A NURSE. DR KASPER WAS OKAY WITH LEAVING THE HARDWARE IN THE PATIENT. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8306787 ↗
• InjuryDec 13, 2018Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  YESTERDAY WITH A BRAND NEW SURGEON, WE WENT TO TAKE OUR FINAL NUMBERS FOR TKA TO SEE IF WE WERE BALANCED WITH ACTUAL IMPLANTS AND THE NUMBERS WERE WAY OFF SO I SAID GRAB GREEN PROBE AND WE DID THE FEMUR CHECK POINT AND IT WAS ALL GOOD THEN WENT TO TIBIA CHECK POINT AND IT WAS OFF LIKE 6MM SO I SAID THE ARRAY MUST HAVE BEEN BUMPED OR CHECK POINT SO I SAID THOSE NUMBERS MIGHT NOT BE ACCURATE AND ASKED SURGEON TO SEE HOW IT FELT AND HE SAID IT LOOKED GOOD SO I SAID OK YOU CAN REMOVE EVERYTHING AND THEY MISSED THE CHECKPOINTS CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8160715 ↗
• InjuryOct 31, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED: "EVENT OCCURRED IN THE OPERATING ROOM. THE SURGEON FORGOT TO REMOVE THE FEMORAL AND TIBIAL CHECKPOINTS FROM HIS FIRST PATIENT ON (B)(6) 2018 BEFORE CLOSING THE SKIN. THE [SURGEON] REMEMBERED WHEN CLOSING THE SECOND PATIENT ON (B)(6) 2018 THAT HE MAY HAVE "FORGOT" TO REMOVE THE CHECKPOINTS FROM THE PREVIOUS PATIENT. AN X-RAY CONFIRMED THAT THE TWO CHECKPOINTS REMAINED IN, AND THE FIRST PATIENT WAS IMMEDIATELY TAKEN BACK TO THE OPERATING ROOM FROM POST-OP THAT SAME DAY IN ORDER TO HAVE THEM REMOVED". POST OP X-RAYS ARE NOT AVAILABLE. THEY DO NOT WANT TO RELEASE THEM TO ME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8025709 ↗