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Triathlon 5530-G-709Recalls & reported problems

Howmedica Osteonics Corp. · Tibial Bearing Insert - CR · Class 2 · Implant

All models of Triathlon (608)

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

Adverse event reports
7
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327045482), received between Dec 20, 2018 and Oct 22, 2019 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 Information4
  • Unstable3
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Injury6
  • Pain2
  • Swelling1
  • Unspecified Infection1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    AS REPORTED: "PATIENT SUFFERED INFECTION FROM ORIGINAL SURGERY, MOST LIKELY DUE TO MRSA POSITIVE STATUS AND DRUG ABUSE." THE PATIENT'S LEFT KNEE WAS REVISED TO A PRIMARY TRIATHLON CONSTRUCT.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 9218086 ↗
  • InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL LEFT TOTAL KNEE ARTHROPLASTY.

    Patient problems: Injury; Pain

    MAUDE report 8964779 ↗
  • InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IN (B)(6) 2017 THE PATIENT GOT A STRYKER KNEE IMPLANT. NOW THE FOLLOWING COMPLAINTS HAVE COME UP WITH PATIENTS: SWOLLEN KNEE, FLUID, PAIN AND HIGHER TEMPERATURE IN THE KNEE.

    Patient problems: Pain; Swelling

    MAUDE report 8821884 ↗
  • InjuryMay 22, 2019Unstable; Unstable

    IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "UNSTABLE LEFT TOTAL KNEE REPLACEMENT".

    Patient problems: Injury

    MAUDE report 8632952 ↗
  • InjuryMay 21, 2019Unstable; Unstable

    IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LEFT KNEE MID FLEXION INSTABILITY AND A CRUCIATE-RETAINING KNEE".

    Patient problems: Injury

    MAUDE report 8629333 ↗
  • InjuryMar 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED, THE PATIENT WAS REVISED DUE TO "FAILED LEFT TOTAL KNEE ARTHROPLASTY WITH PREVIOUS HISTORY OF OSTEOCHONDRAL ALLOGRAFT."

    Patient problems: Injury

    MAUDE report 8449144 ↗
  • InjuryDec 20, 2018Unstable; Unstable

    AS REPORTED: "[SURGEON] PERFORMED A LEFT KNEE REVISION ON [PATIENT] ON (B)(6) 2018. ORIGINAL DATE OF SURGERY WAS (B)(6) 2017. REVISION DUE TO SOME KNEE INSTABILITY NOT ATTRIBUTED TO THE IMPLANT...IMPLANT WILL NOT BE RETURNED. ALL INFORMATION IS CORRECT AND NO MORE INFORMATION IS AVAILABLE". SPOKE TO REP, REP CONFIRMED THE HOSPITAL AND SURGEON WOULD NOT RELEASE ANY ADDITIONAL INFORMATION.

    Patient problems: Injury

    MAUDE report 8187922 ↗

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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