Triathlon 5531-G-716Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327046021), received between Jun 18, 2018 and Jul 24, 2018 — classified as 2 injuries.

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

• InjuryJul 24, 2018Material Deformation; Material Deformation

  PATIENT'S WIFE CALLED STATING HER HUSBAND HAD A STRYKER TOTAL KNEE IMPLANTED IN 2014. 10 MONTHS POST-IMPLANT, KNEE WAS REVISED DUE TO A DAMAGED POLY INSERT (PATIENT'S WIFE REPORTED THE DEVICE WAS "TORN UP" AND "IN CHUNKS"). PATIENT'S WIFE SPECIFIED IMPLANT TOOK PLACE (B)(6) 2012, REVISION (B)(6 2013.

  Patient problems: Injury

  MAUDE report 7714022 ↗
• InjuryJun 18, 2018Crack; Crack

  PATIENT REPORTED THAT HE HAD BILATERAL KNEE SURGERY ON (B)(6) 2010. PATIENT PRESENTED TO THE ER IN LATE (B)(6) 2017 AS HE COULDN'T WALK AND HIS LEG WOULDN'T STRAIGHTEN OUT. HE STATED THEY TOOK X-RAY IMAGES BUT COULDN'T FIND ANYTHING WRONG. FOR THE FOLLOWING TWO MONTHS HE WENT TO SEVERAL APPOINTMENTS AS HE WAS STILL IN PAIN AND HIS KNEE WAS LOCKING. THE EVENT IS FOR THE PATIENT'S RIGHT KNEE. PATIENT STATED THE SURGEON CONFIRMED THE BARING WAS SHATTERED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 7611371 ↗