NA 2178-65-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295096702), received between Jul 10, 2017 and Aug 8, 2022 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED THAT THE SIZE 6 SIGMA SIZER BROKE WHILE TRIALING. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15182310 ↗
• MalfunctionAug 1, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT PLATE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141891 ↗
• MalfunctionJan 5, 2022Break; Break

  PLASTIC SIZER BROKE INTO TWO PIECES. BOTH PIECES WERE RECOVERED. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171081 ↗
• MalfunctionJul 25, 2020Crack; Crack

  IT WAS REPORTED THAT BOTH DEVICES WERE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10324195 ↗
• MalfunctionMay 19, 2020Crack; Crack

  IT WAS REPORTED THAT DURING POST CLEANING INSPECTION THE VIEW PLATE WAS FOUND TO HAVE MULTIPLE CRACKS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10072998 ↗
• MalfunctionMay 20, 2019Break; Break

  TRAY WAS SPLIT IN HALF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8624929 ↗
• MalfunctionApr 11, 2019Break; Break

  IT WAS REPORTED THAT DURING POST WASH CYCLE, THE MBT REV TIBIAL VIEW PLT SZ6 WAS FOUND INSIDE THE MBT REVISION SET BROKE INTO TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8504764 ↗
• MalfunctionFeb 18, 2019Crack; Crack

  IT WAS REPORTED THAT WHILE TRIALING, THE KNEE WAS PUT THROUGH RANGE OF MOTION AND THE TRIAL WAS CRACKED IN HALF. THE TRIAL WAS THEN SIZED UP TO A 6 VIEW PLATE WHICH WAS ALSO CRACKED DURING TRIALING. NO TIME WAS ADDED TO THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347306 ↗
• MalfunctionDec 20, 2018Crack; Crack

  IT WAS REPORTED THAT THE TRIALS ARE CRACKED. HUDSON WILL NOT LOCK ONTO REAMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184799 ↗
• MalfunctionOct 25, 2018Break; Break

  IT WAS REPORTED THAT THE SIZE 6 TEMPLATE DISK HAS SNAPPED IN HALF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006297 ↗
• MalfunctionAug 30, 2018Break; Break

  IT WAS REPORTED THAT THE TIBIA VIEW PLATE BROKE. NO SURGICAL DELAY. NO PIECES OF INSTRUMENTATION LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832435 ↗
• MalfunctionAug 28, 2018Crack; Crack

  IT WAS REPORTED THAT CLEAR POLY TRIALS ARE CRACKED AND DAMAGED AND CANNOT BE USED FOR SURGERY. NOTHING WAS LEFT IN PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822400 ↗
• MalfunctionJul 27, 2018Break; Break

  IT WAS REPORTED THAT MBT REVISION TIBIAL VIEW PLATE SZ 6 IS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726262 ↗
• MalfunctionApr 18, 2018Break; Break

  IT WAS REPORTED THAT INSTRUMENT CRACKED OVER TIME AND FINALLY BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7439479 ↗
• MalfunctionMar 5, 2018Break; Break

  THE MBT REV TIBIAL VIEW PLATE SIZE 6 BROKE IN THE WASHER STERILIZER AFTER THE SURGERY. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7312733 ↗
• MalfunctionFeb 21, 2018Break; Break

  IT WAS REPORTED THAT IT WAS RECENTLY NOTICED THE ATTUNE RP TIBIAL IMPACTOR AND THE SIZE 6 MBT VIEW PLATE WERE CRACKED AND BROKEN. NO TIME ADDED OR ISSUES DURING CASE. ALL PIECES RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286255 ↗
• MalfunctionJan 5, 2018Fracture; Fracture

  IT WAS STATED THAT, NOTICED A SIZE 6 MBT SIZER DISK WAS BROKEN AFTER INSPECTION WHEN CAME THROUGH THE WASH. PLEASE SEND REPLACEMENT (B)(4). DOI: (B)(6) 2017; DOR: (B)(6) 2017; UNK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167724 ↗
• MalfunctionDec 12, 2017Break; Break

  INSTRUMENT WAS FOUND BROKEN IN THE INSTRUMENT SET DURING THE BEGINNING OF THE CASE. NOT USED IN SURGERY BUT NEED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7107625 ↗
• MalfunctionSep 8, 2017Break; Break

  IT WAS REPORTED THAT THE MBT REV TIBIAL VIEW PLT SZ6 RETURNED TO OFFICE AND WAS BROKEN. NOT USED IN SURGERY.

  Patient problems: No Information

  MAUDE report 6851652 ↗
• MalfunctionJul 17, 2017Break; Break

  IT WAS REPORTED THAT THE SIZE 6 MBT REVISION PLATE WAS BROKEN WHEN TRAY WAS OPENED.

  Patient problems: No Information

  MAUDE report 6716771 ↗
• MalfunctionJul 10, 2017Break; Break

  IT WAS REPORTED THAT THE MBT REV TIBIAL VIEW PLATE SZ6 WAS OBSERVED TO BE BROKEN BEFORE SURGERY. IT WAS REPLACED BEFORE CASE STARTED AND WAS NOT USED.

  Patient problems: No Information

  MAUDE report 6698424 ↗