Triathlon 5620-B-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327015546), received between Jul 2, 2019 and Jul 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2019Manufacturing, Packaging or Shipping Problem; Packaging Problem; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  PRIMARY PROCEDURE, LEFT STRYKER PARTIAL KNEE. IT WAS REPORTED THAT UPON OPENING THE BOX FOR A SIZE 4 LEFT MEDIAL TIBIAL. BASEPLATE, THE DEVICE AND IMPLANT STICKERS INSIDE THE BOX WERE FOR A 3X8 LEFT MEDIAL TIBIAL INSERT. THE SURGEON ELECTED TO WAIT FOR THE CORRECT IMPLANT TO BE RETRIEVED, BUT AFTER 1 HOUR 15 MINUTES (BOTH WITH AND WITHOUT USE OF TOURNIQUET) DECIDED TO CEMENT IN A SIZE 3 TIBIAL BASEPLATE. THE ORIGINAL 3X8 INSERT WAS NOT USED, A 4X8 INSERT WHICH HAD BEEN OPENED (AS PER ORIGINAL SURGICAL PLAN) WAS WASTED, AND A DIFFERENT 3X8 INSERT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THE OUTER BOX, DEVICE STICKERS, AND DEVICE IN ITS STERILE BLISTERS HAVE BEEN RETAINED.

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

  MAUDE report 8752404 ↗

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