Triathlon 5630-G-129Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327015836), received between May 22, 2018 and May 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionMay 22, 2018Difficult to Insert; Difficult to Insert

  PRIMARY PROCEDURE, RIGHT PKA. IT WAS REPORTED THAT THE INSERT WOULD NOT SEAT INTO THE BASEPLATE. A 2ND IMPLANT WAS AVAILABLE, USED, AND PERFORMED AS EXPECTED. REP REPORTED A 15-20 MINUTE SURGICAL DELAY WITH USE OF TOURNIQUET. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7532649 ↗

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