R3 71365148Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010599469), received between Jul 24, 2020 and Nov 23, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861453 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487929 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS NOTICED THAT THE NAIL PROX DROP ((B)(4)) HAS A DEFECTIVE ATTACHMENT. FOUR GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD ((B)(4)), THE SCREWDRIVER RELEASE HANDLE ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM RIGHT ((B)(4)) , THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT ((B)(4)), 0 DEG 32 MM TRIAL 48 MM ((B)(4)), THE HONEYCOMB ((B)(4)), THE BOX CHISEL ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11 MM RIGHT ((B)(4)), THE LAG SCREW 3.2 GUIDE PIN SLEEVE ((B)(4)), THE MEDIUM HEXDRIVER ((B)(4)), THE SUBTROC LAG SCREW DRIVER ((B)(4)), THE ACCORD DUAL ENDED HEX DRIVER ((B)(4)) TWO THIN OSTEO BLADE 8X3 ((B)(4)), THE THIN OSTEO BLADE 12X3 ((B)(4)) AND THE JOURNEY DCF AP FEM CUT BLK 4 ((B)(4)) WERE NOTICED CRACKED. THE NAIL PROX DROP ((B)(4)), THE META ANTERIOR DROP ((B)(4)), THE MI Z HANDLE ACET REAMER ((B)(4)) AND TWO THIN OSTEO BLADE 8X3 ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593376 ↗
• MalfunctionFeb 28, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE 0 DEGREE 32MM INNER DIAMETER TRIAL ACETABULAR LINER 48MM, WOULD NOT STAY SEATED INTO THE CUP. NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11390982 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT THE R3 0DEG 32MM TRIAL 48MM WAS FOUND TO BE CRACKED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10319560 ↗