Triathlon 5630-G-208Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327015843), received between Dec 13, 2018 and Dec 13, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2018Difficult to Insert; Difficult to Insert

  STRYKER TRIATHLON SIZE 2 BY 8MM THICK POLYETHYLENE FAILED TO SEAT IN STRYKER TRIATHLON PKR SIZE 2 BASE PLATE. AFTER FIRST POLYETHYLENE COMPONENT WAS DAMAGED 4 MORE POLYETHYLENE COMPONENT FAILED TO SEAT. IT WAS LATER REPORTED THAT THE TOTAL SURGICAL DELAY APPROXIMATELY 2 HOURS WITH TOURNIQUET IN USE. SURGEON DECIDED TO CONVERT THE PROCEDURE TO A TOTAL KNEE PROCEDURE.

  Patient problems: Injury

  MAUDE report 8161362 ↗
• InjuryDec 13, 2018Difficult to Insert; Difficult to Insert

  STRYKER TRIATHLON SIZE 2 BY 8MM THICK POLYETHYLENE FAILED TO SEAT IN STRYKER TRIATHLON PKR SIZE 2 BASE PLATE. AFTER FIRST POLYETHYLENE COMPONENT WAS DAMAGED, 4 MORE POLYETHYLENE COMPONENTS FAILED TO SEAT. IT WAS LATER REPORTED THAT THE TOTAL SURGICAL DELAY APPROXIMATELY 2 HOURS WITH TOURNIQUET IN USE. SURGEON DECIDED TO CONVERT THE PROCEDURE TO A TOTAL KNEE PROCEDURE.

  Patient problems: Injury

  MAUDE report 8160299 ↗

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