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Triathlon 5630-G-108Recalls & reported problems

Howmedica Osteonics Corp. · Tibial Insert · Class 2 · Implant

All models of Triathlon (608)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327015768), received between Sep 21, 2020 and Apr 13, 2021 — classified as 2 injuries.

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

Device problems

  • Insufficient Device Problem Information1
  • Unstable1

Patient problems

  • Joint Laxity1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PT. RECEIVED BILATERAL PKR(S) BACK IN 2019, AND PRESENTED RECENTLY WITH PAIN OF THE LEFT KNEE. THE DR REVISED THE PKR TO A TRIATHLON TKA USING A UNIVERSAL BASEPLATE. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS. NO FURTHER INFORMATION IS BEING MADE AVAILABLE, AND EXPLANTED ITEMS ARE NOT AVAILABLE FOR RETURN DUE TO HOSPITAL-POLICY.

    Patient problems: Pain

    MAUDE report 11655489 ↗
  • InjurySep 21, 2020Unstable; Unstable

    IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SOFT TISSUE INSTABILITY. A TRIATHLON PKR KNEE WAS REVISED TO A TRIATHLON PS KNEE AND ASYMMETRIC PATELLA.

    Patient problems: Joint Laxity

    MAUDE report 10559100 ↗

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

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

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