Triathlon 5620-B-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327015508), received between Dec 13, 2018 and Sep 17, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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 16, 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.

• InjurySep 17, 2019Fracture; Fracture

  ON (B)(6) 2019, INITIAL PROCEDURE DID. ON (B)(6) 2019, IT WAS FRACTURED A TIBIA AS PLAN.

  Patient problems: Injury

  MAUDE report 9075204 ↗
• InjurySep 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019 KNEE JOINT REPLACEMENT DID. ON (B)(6) 2019, THE PATIENT COMPLAINED OF PAIN AND HAD A FRACTURE IN THE TIBIA. AT FIRST, DR. DECIDED THAT IT WAS A TECHNICAL PROBLEM, BUT THERE WAS A FRACTURE STARTING FROM THE EXTENSION OF THE INNER PEG. # 2 HAD THE SAME LENGTH AS THE PEG # 3, # 1 AND # 2 ARE TOO LONG. THERE ARE NO REVISIONS, ETC., AND FOLLOW-UP IS IN PROGRESS.

  Patient problems: Bone Fracture(s)

  MAUDE report 8955493 ↗
• InjuryDec 13, 2018Mechanical Problem; Mechanical Problem

  STRYKER TRIATHLON SIZE 2 BY 8MM THICK POLYETHYLENE FAILED TO SEAT IN STRYKER TRIATHLON PKR SIZE 2 BASE PLATE. AFTER FIRST POLYETHYLENE WAS DAMAGED 4 MORE POLYETHYLENES FAILED TO SEAT. UPDATE (B)(6) 2018: SPOKE TO REP. 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 8160708 ↗

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