Triathlon 5630-G-428Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327016048), received between Jul 3, 2018 and Jul 3, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K071881, K082567, K203099); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED FROM A UNI TO A TOTAL KNEE DUE TO WEAR (SURGEON REPORTED SUSPICION OF WEAR CAUSED BY A FOREIGN BODY). NO DEVICES OBSERVED TO BE LOOSE OR BROKEN. PATIENT WAS REVISED TO A TRIATHLON CR TOTAL KNEE CONSTRUCT. ON (B)(6) 2018: AS PER VOICEMAIL FROM SALES REP, THE INSERT WAS WORN.

  Patient problems: Injury

  MAUDE report 7658779 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071881, K082567, K203099. One submission often covers many models, so check the product and lot details in each record.

• Z-0869-2009 · Nov 25, 2008 · Terminated
  Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling