Triathlon 5517-F-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327041606), received between May 17, 2018 and Dec 11, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PATIENT REVISE DUE TO METAL ALLERGY. PATELLA WAS RETAINED. USED COMPETITOR IMPLANTS AND ONE OF OUR CONES. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY."

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18307839 ↗
• InjuryOct 25, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A TRIATHLON 2X11 INSERT WAS REVISED TO A THICKER INSERT. INTRA-OPERATIVELY, THE ANTERIOR LIP OF THE LINER APPEARED TO BE WORN. THE SURGEON WOULD LIKE THE LINER INVESTIGATED. REP PROVIDED THE PRIMARY OPERATIVE REPORT AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 12689890 ↗
• InjuryJun 19, 2018Device-Device Incompatibility; Device-Device Incompatibility

  THIS EVENT IS FOR THE SAME-DAY REVISION OF PATIENT'S KNEE. THE INCORRECT FEMORAL COMPONENT WAS IMPLANTED DUE TO HUMAN ERROR. THEY REVISED THE PATIENT THE SAME DAY AND LEFT THE CR FEMUR IMPLANTED BUT EXCHANGED THE PS INSERT TO A CS INSERT TO ADJUST FOR THE FEMORAL ERROR SO THAT THE SURGEON WAS SATISFIED WITH THE PATIENT¿S KNEE CONSTRUCT.

  Patient problems: Injury

  MAUDE report 7614352 ↗
• InjuryMay 17, 2018Loss of Osseointegration; Loss of Osseointegration

  PHYSICIAN IMPLANTED A TRIATHLON BEADED PA FEMUR, TRITANIUM TIBIA, AND TRITANIUM PATELLA ON (B)(6) 2017. HE STATES THAT THE PATIENT REPORTED PAIN AND DISSATISFACTION. THE PATIENT ELECTED TO SEE ANOTHER PHYSICIAN FOR CONTINUED TREATMENT. ACCORDING TO THE NEW PHYSICIAN, A BONE SCAN REVEALED POTENTIAL FOR LOOSENING OF THE FEMORAL COMPONENT. THE PHYSICIAN ELECTED TO REMOVE THE FEMORAL COMPONENT AND IMPLANT A CEMENTED TRIATHLON PS FEMUR AND PS X3 INSERT.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 7523444 ↗