Triathlon 5552-L-381Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327013566), received between Feb 7, 2017 and Feb 24, 2026 — classified as 5 injuries, 2 malfunctions.

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

Recent adverse event reports

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

• MalfunctionFeb 24, 2026Activation, Positioning or Separation Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THE TRITANIUM ASYMMETRIC PATELLA SZ 38 THAT WAS OPENED DID NOT STICK TO BONE AND WOULD FALL OUT ONCE IMPLANTED WITH THE TRITANIUM PREP TRAY PATELLA CLAMP. CEMENTED THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428466 ↗
• InjuryOct 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATELLA DISLOCATED POST TOTAL KNEE REPLACEMENT WHICH WAS PERFORMED ON (B)(6) 2025. NO IMPLANTS WERE REVISED. SURGEON WAS ABLE TO DO A LATERAL RELEASE TO GAIN STABILITY WITHOUT CHANGING ANY IMPLANTS.

  Patient problems: Joint Dislocation

  MAUDE report 23334683 ↗
• InjuryAug 12, 2021Unstable; Unstable

  AS REPORTED: "DR. REVISED A LEFT KNEE DUE TO PATELLA INSTABILITY. THE TIBIA BASEPLATE WAS NOT REVISED. ALL OTHER COMPONENTS CAME OUT." A TRIATHLON CR FEMORAL COMPONENT, TRIATHLON CR X3 INSERT, AND TRITANIUM PATELLA WERE REVISED TO A TS FEMUR, PS INSERT, AND PATELLA WITH A STEM, CONES, AND AUGMENTS. PER REP: THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER OR THE ROBOT USED TO COMPLETE THE PRIMARY SURGERY.

  Patient problems: Joint Laxity

  MAUDE report 12311962 ↗
• InjuryMar 23, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S ENTIRE CR KNEE WAS REVISED TO A TS KNEE. REP PROVIDED PRIMARY USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11554965 ↗
• InjuryApr 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO ANTERIOR KNEE PAIN. THE PATELLA WAS REVISED.

  Patient problems: Injury; Pain

  MAUDE report 7400984 ↗
• InjuryDec 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A TRIATHLON TRITANIUM PATELLA AND CS TIBIAL INSERT DUE TO TIGHTNESS. HE REAMED MORE PATELLA BONE OFF AND REVISED TO A CEMENTED PATELLA WITH A THINNER TIBIAL INSERT. THE ORIGINAL SURGERY WAS (B)(6) 2017.

  Patient problems: Injury

  MAUDE report 7153024 ↗
• MalfunctionFeb 7, 2017Connection Problem; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REP REPORTED A LEFT KNEE SURGERY. THE PRODUCT DID NOT FIXATE WELL AND WAS UNABLE TO BE RETAINED. SALES REP INDICATED THAT THE PROPER DRILL WAS USED & DEVICE CHECKED. SURGEON CEMENTED TKA RATHER THAN PRESSFIT.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6307276 ↗