Triathlon 5516-F-602Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327041583), received between Nov 22, 2017 and Jun 2, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (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. 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.

• InjuryJun 2, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED. ON (B)(6) 2023, IT WAS DISCOVERED POST-OP THAT A RIGHT-SIDED FEMORAL COMPONENT WAS IMPLANTED INTO THE PATIENT'S LEFT KNEE. PATIENT WAS CONSENTED FOR REVISION BUT REVISION COULD NOT BE PERFORMED UNTIL THE NEXT DAY. THE FEMORAL COMPONENT AND INSERT WERE REVISED (REP CONFIRMED INSERT WAS ONLY REVISED TO ALLOW ACCESS TO THE FEMORAL COMPONENT).

  Patient problems: Insufficient Information

  MAUDE report 17047777 ↗
• MalfunctionAug 31, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT SURGEON WAS PERFORMING A PRIMARY KNEE SURGERY AND UPON OPENING THE IMPLANT, THE INNER BOX/BLISTER WAS BROKEN AND SURGEON THOUGHT STERILITY MAY BE COMPROMISED AS A RESULT AND OPTED NOT TO USE THIS DEVICE BUT ANOTHER WAS ON HAND AND READILY AVAILABLE SO SURGEON USED ANOTHER DEVICE OF SAME SIZE/CAT AND COMPLETED THE SURGERY WITHOUT ANY DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837155 ↗
• MalfunctionNov 22, 2017Packaging Problem; Packaging Problem

  A DISTRIBUTOR REPORTED THAT: "BEFORE THE SURGERY, WHEN PREPARING THE DEVICES, THE MEDICAL STAFF OBSERVED THAT THE PACKAGING WAS NOT DAMAGED BUT THE INNER PLASTIC SHELL IS BROKEN AT THE WELD. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7054183 ↗