Triathlon 5630-G-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327016062), received between Dec 16, 2021 and Dec 16, 2021 — classified as 1 injury.

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.

• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A STUDY SUBJECT IN THE TRIATHLON PKR OUTCOMES STUDY. THE SITE ATTRIBUTED THIS TO A SPORTS INJURY. THE SUBJECT HAD HIS ORIGINAL PKR SURGERY ON (B)(6) 2016 FOR THE MEDIAL COMPARTMENT. ON 4/18/2017, AN ADVERSE EVENT WAS REPORTED NOTING PROGRESSION OF OSTEOARTHRITIS ON THE LATERAL COMPARTMENT AND PATELLA-FEMORAL AREA TREATED WITH SEVERAL INJECTIONS OF SUPARTZ AND STEROIDS. THE EVENT WAS CONSIDERED RESOLVED AS OF 8/25/2017. ON 2/16/2018, IT WAS REPORTED THAT THE SUBJECT SUSTAINED A TRAUMA AND EXPERIENCED A LATERAL MENISCUS TEAR. A PLM AND CHONDROPLASTY WAS PERFORMED VIA ARTHROSCOPY ON (B)(6)2018 AND THE EVENT WAS CONSIDERED RESOLVED. AT THIS TIME, IT WAS OBSERVED THAT THERE WERE GRADE 2-3 CHANGES IN PATELLA-FEMORAL AND GRADE 3-4 CHANGES IN LATERAL COMPARTMENT. ON (B)(6) 2018, IT WAS NOTED THAT THERE WAS PROGRESSION OF THE ARTHRITIC DEGENERATION IN THE LATERAL COMPARTMENT AND THE SUBJECT STARTED COMPLAINING ABOUT MORE PAIN. IT WAS DECIDED TO CONVERT THE MEDIAL TRIATHLON PKR TO A TOTAL KNEE.

  Patient problems: Arthritis; Pain

  MAUDE report 13017972 ↗

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