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Triathlon 5537-G-722Recalls & reported problems

Howmedica Osteonics Corp. · Total Stabilizer+ 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 07613327027518), received between Sep 16, 2019 and May 18, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 Information2

Patient problems

  • Pain2
  • Injury1

Recent adverse event reports

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

  • InjuryMay 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    AS REPORTED: "DR. PERFORMED RIGHT KNEE REVISION DUE TO ANTERIOR KNEE PAIN. COMPONENTS ARE NOT AVAILABLE PER HOSPITAL POLICY AND NO MORE INFORMATION IS AVAILABLE PER DOCTOR".

    Patient problems: Pain

    MAUDE report 11840075 ↗
  • InjurySep 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "PATIENT PRESENTED TO CLINIC WITH ANTERIOR KNEE PAIN. 7X22 TS INSERT TAKEN OUT AND REPLACED WITH A 7X22 TS INSERT. NATIVE PATELLA RESURFACED WITH STRYKER 40MM ASYMMETRIC PATELLA. INSERT WAS NOT DAMAGED PRIOR TO REMOVAL OF THE INSERT...". SPOKE TO REP, WHO PROVIDED AN EXPLANT PICTURE, OUTER BOX PICTURES OF THE REVISION IMPLANTS, AND A 2017 OPERATIVE REPORT. REP CONFIRMED THAT INFORMATION PROVIDED IS EVERYTHING THAT IS AVAILABLE.

    Patient problems: Injury; Pain

    MAUDE report 9070584 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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