RESTORIS, RIO 206270Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00848486022082), received between Jun 4, 2018 and Nov 26, 2019 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Break” (35 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2019Fracture; Separation Failure; Fracture; Separation Failure

  IMPACTION CAP/PLATE WOULD NOT DISENGAGE FROM THE IMPACTOR AFTER IMPACTION. PIECES ARE STILL TOGETHER AND IT APPEARS THE CAP DISENGAGE IS BROKEN CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9378969 ↗
• MalfunctionNov 26, 2019Fracture; Difficult to Insert; Fracture; Difficult to Insert

  DURING IMPACTION, THE OFFSET IMPACTOR BROKE AT THE ATTACHMENT AREA FOR THE IMPACTION PAD. WHEN WE TRIED TO PUT THE IMPACTION PAD ON ANOTHER IMPACTOR IT WOULD NOT FIT OR LOCK ON. THE IMPACTOR SHAFT COMPLAINT WAS RECORDED IN (B)(4) CASE TYPE: THA SURGICAL DELAY; X <= 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9378966 ↗
• MalfunctionNov 26, 2019Fracture; Fracture

  IMPACTION PLATFORM BROKE WHILE IMPACTING. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9378235 ↗
• MalfunctionNov 26, 2019Fracture; Fracture

  MAKO TOTAL HIP CUP IMPACTOR PAD BROKEN ON REMOVAL FROM END EFFECTOR/IMPACTOR POST CUP IMPACTION. CUP IMPACTION COMPLETED BEFORE ISSUE AND NO REPLACEMENT NEEDED. MALE PATIENT UNDERGOING TOTAL HIP ARTHROPLASTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9378109 ↗
• MalfunctionNov 15, 2019Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  PRONG ON IMPACTION PLATFORM BROKE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9327525 ↗
• MalfunctionNov 8, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  SPRING INSIDE IMPACTION PLATFORM POPPED OUT DURING IMPACTION. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9295405 ↗
• MalfunctionOct 1, 2019Material Integrity Problem; Material Integrity Problem

  INLINE OFFSET IMPACTOR FRACTURED WHILE SURGEON WAS IMPACTING CUP. IMPACTOR PLATE AND HIP END EFFECTOR WERE DAMAGED AS WELL, I HAD REPLACEMENT SET OF INSTRUMENTS TO OPEN ONTO THE STERILE FIELD, SURGEON HAD DIFFICULTY REMOVING BROKEN INSTRUMENTS OFF OF THE ROBOT, WHICH ADDED TO THE DELAY IN SURGERY. CASE TYPE: THA. SURGICAL DELAY: 35 MINUTES. THIS COMPLAINT IS FOR 206270 SHELL IMPACTION PLATFORM. ASSOCIATED COMPLAINTS FROM THE SAME SURGERY INCLUDE: PI 2198767, PI 2198777 AND PI 2198959. UPDATE: "YES, THE PATIENT WAS UNDER ANESTHESIA."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9141694 ↗
• MalfunctionOct 1, 2019Fracture; Fracture

  IMPACTOR PLATE FRACTURED WHILE SURGEON WAS IMPACTING CUP. INLINE OFFSET IMPACTOR AND HIP END EFFECTOR WERE DAMAGED AS WELL, I HAD REPLACEMENT SET OF INSTRUMENTS TO OPEN ONTO THE STERILE FIELD, SURGEON HAD DIFFICULTY REMOVING BROKEN INSTRUMENTS OFF OF THE ROBOT, WHICH ADDED TO THE DELAY IN SURGERY. CASE TYPE: THA. SURGICAL DELAY: 35 MINUTES. THIS COMPLAINT IS FOR THE 206270 SHELL IMPACTION PLATFORM. ASSOCIATED COMPLAINTS FROM THE SAME SURGERY INCLUDE: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9141325 ↗
• MalfunctionSep 24, 2019Break; Fracture; Break; Fracture

  IMPATOR PLATE WILL NOT LOCK INTO PLACE. CASE TYPE: THA. PER INTAKE RESPONSE: 9/9/2019 THA WITH BROKEN IMPACTOR PLATE.

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

  MAUDE report 9110812 ↗
• MalfunctionSep 18, 2019Break; Fracture; Break; Fracture

  AFTER IMPACTION THE STRIKE PLATE BROKE INTO A FEW PIECES. THIS RESULTED IN NOT BEING ABLE TO DISASSEMBLE REMAINING PIECE OF THE STRIKE PLATE, THE IN-LINE OFFSET IMPACTOR (209830-LOT UNKNOWN), AND THE END EFFECTOR (206967, LOT: 19021214). THE INLINE OFFSET MIGHT BE BENT WHICH MIGHT BE CAUSING THE INABILITY TO PASS THROUGH THE STRIKE PLATE. BUT THE END EFFECTOR SHOULD NOT BE DAMAGED IN ANY CAPACITY. HOWEVER ALL THREE PIECES ARE NO LONGER EFFECTIVE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9081447 ↗
• MalfunctionSep 17, 2019Break; Fracture; Break; Fracture

  IMPACTION PLATFORM BROKE DURING CUP IMPACTION. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9078024 ↗
• MalfunctionSep 9, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  IMPACTION PLATFORM BROKE IN HALF WHILE SURGEON WAS IMPACTING IMPLANT. CASE TYPE: THA. SURGICAL DELAY: 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8975124 ↗
• MalfunctionSep 5, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  WENT TO IMPACT CUP AND MAKO SHELL IMPACTOR BROKE. HIGH VOLUME ACCOUNT NEEDING REPLACEMENT ASAP. CASE TYPE: THA. 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8966873 ↗
• MalfunctionAug 29, 2019Break; Difficult to Insert; Break; Difficult to Insert

  IMPLACTION PLATFORM STRIKE PLATE WILL NOT ENGAGE WITH THE CUP IMPACTOR.. THE ENGAGING BUTTON APPEARS TO BE BROKEN NOT ALLOWING THE STRIKE PLATE TO BE SEATED ON THE IMPACTOR. CASE TYPE: THA. SURGICAL DELAY: =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946468 ↗
• MalfunctionAug 13, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  DURING A MAKO THA PROCEDURE, CUP IMPACTION WAS SUCCESSFUL AND COMPLETED. UPON DISMANTLING THE MAKO CUP INSERTER, THE "IMPACTION PLATFORM" WAS CRACKED AND FELL APART UPON REMOVAL FROM THE IMPACTOR SHAFT. UPDATE: WAS THE PATIENT UNDER ANESTHESIA WHEN THE EVENT OCCURRED? YES. 2. WERE ANY DEBRIS/COMPONENTS LEFT INSIDE OF THE PATIENT? NO DEBRIS WAS LEFT INSIDE THE PATIENT, SURGEON WAS HAPPY THAT ALL DEBRIS/ PARTS OF THE BROKEN COMPONENT WERE ACCOUNTED FOR. 3. WERE ANY COMPONENTS OF THE DEVICE MISSING OR DISASSEMBLED WHEN THE ISSUE OCCURRED? NO, THE COMPONENT WAS COMPLETE WHEN THE ISSUE OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889030 ↗
• MalfunctionAug 2, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  IMPACTION PLATFORM BROKE DURING IMPACTION. CASE TYPE: THA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8858157 ↗
• MalfunctionJul 23, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  TODAY WHILE DOING A MAKO THA, WE NOTICED THE IMPACTION PLATFORM WAS BROKEN AFTER DR. (B)(6) HAD FINISHED IMPACTING THE CUP. THE CASE WAS COMPLETED ROBOTICALLY WITHOUT ISSUE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8817066 ↗
• MalfunctionJul 22, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  SURGEON HIT THE CUP IMPACTOR ON THE SIDE OF THE PLATE BREAKING THE PLATE AND BENDING THE IMPACTOR. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8814502 ↗
• MalfunctionJul 16, 2019Break; Fracture; Break; Fracture

  WE HAD AN IMPACTION PLATFORM SHATTER UPON CUP IMPACTION TODAY. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8795204 ↗
• MalfunctionJul 3, 2019Break; Fracture; Break; Fracture

  IMPACTING BLOCK BROKE DURING IMPACTION, BENDING OFFSET IMPACTOR IN PROCESS. CASE TYPE: THA.

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

  MAUDE report 8760052 ↗
• MalfunctionJul 2, 2019Break; Break

  IMPACTION PLATFORM BROKE DURING IMPACTING . CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8754370 ↗
• MalfunctionJun 26, 2019Fracture; Non Reproducible Results; Fracture; Non Reproducible Results

  PLATFORM BROKE WHILE IMPACTING CUP. CASE TYPE: THA. SURGICAL DELAY: 5 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8736873 ↗
• MalfunctionJun 26, 2019Fracture; Fracture

  BROKE DURING IMPACTION. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8736797 ↗
• MalfunctionMay 31, 2019Break; Break

  THE END OF THE MAKO STRAIGHT CUP IMPACTOR BROKE OFF INSIDE OF THE IMPACTION PLATFORM. CASE TYPE: THA. UPDATE: "YES THE IMPACTOR BROKE DURING IMPACTION".

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

  MAUDE report 8657972 ↗
• MalfunctionMay 24, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  DURING IMPACTION, IMPACTION PLATFORM AND THE BACK ON THE INLINE-OFFSET IMPACTION BROKE. THE PLATFORM CRACKED IN HALF WHILE TAKING A PIECE OF THE BACK OF THE IMPACTOR. IMPACTION WAS STILL COMPLETED WITH THE ROBOT WITH NO PATIENT HARM AND OUTCOMES WERE NOT EFFECTED. CASE TYPE: THA. UPDATE: "NO DEBRIS/COMPONENTS WERE LEFT INSIDE OF THE PATIENT. NO COMPONENTS OF THE DEVICE WERE MISSING OR DISASSEMBLED WHEN THE ISSUE OCCURRED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8642196 ↗