NA 111644Recalls & reported problems
Mako Surgical Corp. · KNEE FEMORAL CHECKPOINT · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486029487), received between May 31, 2018 and Dec 17, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Insufficient Device Problem Information1
- Material Fragmentation1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 REMOVEL OF THE PIN AND PROCEDURE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826240 ↗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 23486966 ↗InjuryMay 31, 2018Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information
DR. (B)(6) MADE A COMMENT DURING A CASE THAT SEVERAL MONTHS PRIOR HE HAD LEFT IN A FEMORAL CHECKPOINT DURING A PFJ PROCEDURE. IT WAS DISCOVERED ON THE PATIENT¿S FOLLOW UP VISIT TO HIS OFFICE AND REMOVED WITHIN A COUPLE DAYS OF DISCOVERY. SURGEON DID NOT PROVIDE PATIENT INITIALS. HOSPITAL DOES NOT PROVIDE POST OP X-RAYS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7557320 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.