NA 111651Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00848486001353), received between Sep 28, 2018 and May 14, 2026 — classified as 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Use of Device Problem

  DURING THE POST-CLOSURE X-RAY EXAMINATION, IT WAS DISCOVERED THAT A CHECKPOINT SCREW HAD BEEN LEFT IN THE BONE. THIS WAS DUE TO A LACK OF VERIFICATION BY THE PHYSICIAN, (B)(6), AND ALL STAFF MEMBERS. SINCE THE PATIENT WAS STILL UNDER ANESTHESIA, THE INCISION WAS REOPENED AND THE SCREW WAS REMOVED. ALTHOUGH THE SURGERY WAS EXTENDED BY 30 MINUTES, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. REOPENED AND THE SURGERY WAS EXTENDED BY 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171738 ↗
• MalfunctionFeb 18, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: TIBIAL CHECKPOINT (CODE 111651) SNAPPED AT THE TIP WHILST BEING REMOVED FROM PATIENT AT THE END OF A LEFT MAKO PARTIAL KNEE REPLACEMENT. PATIENT AWAITING XR TO SEE IF TIP OF CHECKPOINT IS STILL IN SITU. NOTE THIS X-RAY WOULD HAVE BEEN STANDARD POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380548 ↗
• InjuryDec 17, 2025Use of Device Problem; Use of Device Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS FOUND THAT THE CHECKPOINT PIN USED DURING MAKO SURGERY WAS LEFT IN THE PATIENT'S BODY. POSTOPERATIVE X-RAY REVEALED IT, SO INCISION REOPENED AND CLOSED AGAIN AFTER REMOVAL OF THE PIN AND PROCEDURE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825986 ↗
• MalfunctionDec 3, 2025Material Fragmentation; Material Fragmentation

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705236 ↗
• InjuryDec 2, 2025Use of Device Problem; Use of Device Problem

  NO NEW INFORMATION.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 23691745 ↗
• MalfunctionNov 6, 2025Material Fragmentation; Material Fragmentation

  CHECKPOINTS WERE NOT ADDED TO BACK TABLE COUNT. PLAN WAS ARCHIVED AND EXITED WITHOUT CONFIRMING CHECKPOINTS WERE REMOVED. THEREFORE, CHECKPOINTS (ONE FEMORAL, ONE TIBIAL) WERE LEFT IN PATIENT. THE SURGEON IS NOT PLANNING ON REMOVING CHECKPOINTS. IF THEY BEGIN TO BOTHER THE PATIENT FOLLOWING POST OP APPOINTMENTS, SURGEON WILL DECIDE TO REMOVE. WAS A RIGHT TOTAL KNEE. CASE TYPE / APPLICATION: TKA 2.0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486794 ↗
• MalfunctionOct 29, 2025Use of Device Problem; Use of Device Problem

  THE WOUND WAS CLOSED WITH THE CHECKPOINT PIN REMAINING IN THE FEMUR. AFTER WOUND CLOSURE, RESIDUAL PINS WERE DISCOVERED. AFTER THE WOUND WAS STITCHED, AN X-RAY REVEALED THE REMAINS OF THE PIN IN THE BODY, SO THE WOUND WAS REOPENED AND THE PIN WAS REMOVED WITHOUT WAKING UP THE ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412669 ↗
• InjuryJul 10, 2025Device Handling Problem; Device Handling Problem

  THE FOLLOWING WAS REPORTED "CHECKPOINT WAS LEFT AND CLOSED IN PATIENT. SURGEON IS REMOVING CHECKPOINT 2 DAYS FOLLOWING THE INCIDENT. POST OP XRAY NOT PROVIDED. CASE TYPE / APPLICATION: THA 4.1".

  Patient problems: Insufficient Information

  MAUDE report 22469180 ↗
• InjuryJul 22, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AT THE END OF A LEFT-SIDE MAKO THA 4.1 CASE ON (B)(6) 2024, SURGEON NOTIFIED CSS THAT A CHECKPOINT WAS LEFT IN THE PATIENT. THE PATIENT WAS BROUGHT BACK TO THE OR ON (B)(6) 2024 AND THE CHECKPOINT WAS REMOVED. C SS CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794460 ↗
• InjuryJul 17, 2023Use of Device Problem; Use of Device Problem

  PATIENT WAS HAVING A MAKO THA. ONCE CUP WAS IMPLANTED THE PATIENT HAD A SUSPECTED PULMONARY EMBOLISM. SURGEON CLOSED WOUND TO REPOSITION PATIENT SO THEY COULD BE ASSESSED. SURGERY WAS THEN CALLED OFF. FEMORAL CHECKPOINT WAS LEFT IN THE PATIENT. SURGEON WAS AWARE OF THIS AT THE TIME AND DIDN¿T WANT TO REOPEN THE WOUND TO TAKE IT OUT. UPDATE PER RESPONSE: "PATIENT IS DOING WELL. PROCEDURE WAS COMPLETED THE FOLLOWING WEEK AND CHECKPOINT WAS REMOVED."

  Patient problems: Foreign Body In Patient

  MAUDE report 17332872 ↗
• InjuryOct 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT THA. AFTER THE WOUND WAS CLOSED, I NOTICED THAT I FORGOT TO REMOVE THE CHECKPOINT PIN PLACED ON THE OUTSIDE OF THE GREATER TROCHANTER OF THE RIGHT FEMUR. CONFIRMED WITH A NURSE / SURGEON. THE ANESTHESIA WAS EXTENDED AND THE SURGEON REOPENED AND REMOVED THE CHECKPOINT PIN. THERE WAS NO ABNORMALITY IN THE PIN, AND THE WOUND WAS CLOSED AGAIN AS IT WAS, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10648470 ↗
• InjuryMay 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE WOUND WAS CLOSED WHILE THE TIBIAL PIN REMAINED IN THE FEMUR. I NOTICED BY X-RAY PHOTOGRAPHY. IMMEDIATELY AFTER THAT, AT THE TIME OF THE OPERATION ON THE OPPOSITE SIDE, IT WAS REMOVED. UPDATE: WHY WAS A TIBIAL PIN USED IN THE PATIENT¿S FEMUR? PLEASE CLARIFY OR PROVIDE CORRECTIONS AS NEEDED: THE TIBIAL PIN WAS NOT USED ON THE FEMUR, IT WAS LEFT ON THE FEMUR. DID THE PATIENT¿S WOUND HAVE TO BE RE-OPENED TO REMOVE THE TIBIAL PIN? IMMEDIATELY AFTER THAT, THERE WAS SURGERY ON THE OTHER SIDE, SO THEY REMOVED IT. AT WHAT POINT WAS THE X-RAY TAKEN WHEN THE PIN WAS NOTICED STILL IN THE FEMUR? AFTER CLOSING THE WOUND. DID THE PATIENT COME OUT OF ANESTHESIA BETWEEN THE SIDE WITH THE TIBIAL PIN REMAINING IN THE FEMUR, AND THE START OF THE OPERATION ON THE OPPOSITE SITE? UNK. WHAT SIDE OF THE PATIENT WAS THE ORIGINAL SIDE (THE SIDE WITH THE REPORTED TIBIAL PIN)?LEFT PLEASE ESTIMATE ANY SURGICAL DELAY, EVEN IF UNDER A MINUTE: UNK. WERE ALL PIECES REMOVED? YES, BUT THE METHOD IS UNKNOWN.

  Patient problems: Foreign Body In Patient; Wound Dehiscence

  MAUDE report 10038186 ↗
• MalfunctionJan 31, 2020Fracture; Difficult to Remove; Appropriate Device Problem Term/Code Not Available; Fracture; Difficult to Remove; Appropriate Device Problem Term/Code Not Available

  TIBIA CHECKPOINT WAS LEFT IN PATIENT. CHECKPOINT BECAME DISLODGED DURING TEAMING AND FELL INTO BONY DEFECT IN ACETABULUM AND COULD NOT BE RECOVERED. CASE TYPE: THA. SURGICAL DELAY : 16-30 MINUTES.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 9654852 ↗
• MalfunctionDec 23, 2019Fracture; Fracture

  TIBIA CHECKPOINT TIP BROKE OFF IN PATIENT WHILE EXTRACTING. TIP REMAINING IN PATIENT IS ROUGHLY 2 MM. CASE TYPE: THA. SURGICAL DELAY: = 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511707 ↗
• MalfunctionSep 3, 2019Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  TIBIAL CHECK POINT SHEERED OFF WHEN REMOVING. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8955801 ↗
• InjuryApr 4, 2019Fracture; Fracture

  SURGEON COMMENTED THAT THE GREATER TROCHANTER FRACTURED THROUGH THE INSERTION SITE OF THE PROXIMAL CHECKPOINT DURING THE JOINT REDUCTION WITH STEM IMPLANT AND TRIAL HEAD DURING MAKO DIRECT ANTERIOR APPROACH THA. THE SURGEON ALSO COMMENTED THAT HE DID NOT BELIEVE THAT THE CHECKPOINT CAUSED THE FRACTURE. THE FRACTURE WAS REPAIRED WITH A CERCLAGE CABLE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8485717 ↗
• MalfunctionFeb 20, 2019No Apparent Adverse Event; Non Reproducible Results; No Apparent Adverse Event; Non Reproducible Results

  DURING A MAKO TKA CASE THAT MY COLLEAGUE (B)(6) AND I WERE RUNNING TOGETHER, AFTER ALL CUTS WERE DONE AND IMPLANTS WERE CEMENTED, THE SCRUB NURSE NOTICED THAT THE TIBIAL CHECKPOINT WAS MISSING FROM THE PATIENT¿S TIBIA. SINCE THE CHECKPOINT COULD NOT BE FOUND ANYWHERE, THE SURGEON REQUESTED AN X-RAY OF THE PATIENT BEFORE CLOSING THE WOUND. AT THIS STAGE, THE CHECKPOINT WAS FOUND UNDERNEATH THE IMPLANTED TIBIAL COMPONENT, WHICH AT THAT POINT WAS ALREADY CEMENTED ON BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353291 ↗
• InjurySep 28, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  WHEN REMOVING TIBIAL CHECKPOINT FROM TIBIAL TUBEROSITY, THE CHECKPOINT SNAPPED OFF LEAVING PART OF THE CHECKPOINT IN THE PATIENT. TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920125 ↗