Trident II 702-04-46CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327343809), received between Mar 7, 2022 and Jul 11, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Failure to Advance; Insufficient Device Problem Information; Failure to Advance; Insufficient Device Problem Information

  DURING MAKO THA CASE, SURGEON COMMENTED THAT THERE HAD BEEN A SMALL FRACTURE TO THE POSTERIOR ACETABULUM. MAKO PLAN WAS ORIGINALLY DISCUSSED AND SHOWED SURGEON PLAN WITH 46 CUP, SURGEON ASKED, IF POSSIBLE, TO UPSIZE CUP, SHOWED BIGGER SIZE AND SAID NOT AN APPROPRIATE OPTION DUE TO BEING OVERSIZED, SURGEON HAPPY TO CONTINUE WITH 46 CUP PLAN, WELL SIZED. REAMING HAD BEEN COMPLETED WITH MAKO AS PER USUAL, WHEN TRYING TO IMPACT WITH MAKO, SURGEON WAS HAVING TROUBLE GETTING CUP INTO POSITION, WAS REPORTING THAT THE PATIENT HAS EXTENSIVE SOFT TISSUE AND WAS HAVING TROUBLE GETTING MAKO REAMING HANDLE INTO POSITION. AT THIS POINT HAD RECHECKED PELVIC CHECKPOINT AND TOOL CHECKPOINT AND BOTH HAD PASSED. SURGEONS STATED THAT HE DID NOT WANT TO EXTEND INCISION TO HELP ACCESS, SURGEON HAPPY TO TRY OFFSET IMPACTOR MAKO HANDLE. CHANGED TO OFFSET IMPACTION HANDLE AND CHECKED TOOL CHECKPOINT WHICH PASSED, BUT SURGEON STILL HAVING ISSUES WITH ACCESS AND GETTING MAKO IMPACTION HANDLE INTO GOOD POSITION, STATING THAT PATIENT SOFT TISSUE WAS PUSHING OFF PLANE. SURGEON DECIDED TO MANUALLY IMPACT WITHOUT MAKO IMPACTION HANDLE. SURGEON MANUALLY IMPACTED AND THEN CHECKED SURGICAL RESULTS WITH BLUE PROBE, S

  Patient problems: Bone Fracture(s)

  MAUDE report 22478214 ↗
• InjuryAug 17, 2023Unstable; Unstable

  THIS PI IS FOR THE REVISION ON (B)(6) 2022. PATIENT HAD AN INDEX LEFT THAT ON (B)(6) 2022. PATIENT HAD INSTABILITY AND DISLOCATED, REQUIRING CLOSED REDUCTION UNDER ANESTHESIA ON (B)(6) 2022. PATIENT CONTINUED WITH INSTABILITY AND UNDERWENT REVISION ON (B)(6) 2022. ALL COMPONENTS WERE EXCHANGED EXCEPT THE STEM.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 17562836 ↗
• InjuryMar 7, 2022Unstable; Unstable

  PATIENT HAD AN INDEX LEFT THA ON (B)(6) 2021. PATIENT PRESENTED WITH INSTABILITY AND DISLOCATION OF LEFT HIP. UNDERWENT REVISION FOR INSTABILITY ON (B)(6) 2021. CUP, LINER, AND HEAD WERE EXCHANGED.

  Patient problems: Joint Laxity

  MAUDE report 13677953 ↗