Triathlon 5630-G-228Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327015904), received between Apr 19, 2017 and Apr 21, 2021 — classified as 2 injuries, 1 malfunction.

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

• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED WITH PAIN REQUIRING REVISION OF A RPKR. SURGEON REMOVED THE PKR AND IMPLANTED TRIATHLON/TRIATHLON-TS COMPONENTS. NO COMPLAINTS HAVE BEEN FILED AGAINST THE PKR COMPONENTS." SPOKE TO THE REP, WHO PROVIDED PRIMARY AND REVISION USAGE SHEETS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11704591 ↗
• InjuryOct 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "PATIENT PRESENTED WITH ONGOING PAIN/DISCOMFORT, ULTIMATELY REQUIRING REVISION TO A TKA. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS." SPOKE TO REP, WHO PROVIDED THE PRIMARY AND REVISION USAGE SHEETS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10618855 ↗
• MalfunctionApr 19, 2017Break; Crack; Material Integrity Problem; Positioning Problem; Crack; Material Integrity Problem

  THE INSERT DID NOT SEAT PROPERLY ON THE TIBIAL TRAY AND IT BROKE DURING INSERTION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6503767 ↗

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