Triathlon 5630-G-220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327015881), received between Aug 9, 2019 and Nov 15, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryNov 15, 2019Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDICAL RECORDS PROVIDED FOR LEGAL PI HAVE INDICATED ADDITIONAL TREATMENTS/REVISIONS THE PATIENT UNDERWENT. THIS PI IS FOR A MANIPULATION UNDER ANESTHESIA (MUA) THE PATIENT UNDERWENT ON (B)(6) 2015 DUE TO REPORTED STIFFNESS THE PATIENT WAS EXPERIENCES AFTER IMPLANTATION OF TRIATHLON PKR COMPONENTS IN HER RIGHT KNEE. EXCERPT FROM MEDICAL REVIEW: "ON (B)(6) 2015, AT 3- MONTHS FOLLOW-UP, RIGHT KNEE FLEXION OF ONLY 100° WAS REPORTED DESPITE VIGOROUS PHYSICAL THERAPY. NO FURTHER PROGRESS IN KNEE FLEXION AND PAIN REDUCTION WAS OBTAINED AND CONSEQUENTLY ON (B)(6) 2015, A MANIPULATION UNDER ANAESTHESIA (MUA) OF THE RIGHT KNEE WAS PERFORMED UNDER THE DIAGNOSIS OF ARTHROFIBROSIS ACHIEVING SOME 155° OF KNEE FLEXION."

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 9329152 ↗
• InjuryAug 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO ADVANCEMENT IN DJD RIGHT KNEE WITH A PAINFUL KNEE REPLACEMENT.

  Patient problems: Injury; Pain

  MAUDE report 8880072 ↗

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