Triathlon 5526-B-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327041378), received between Jan 2, 2019 and Oct 21, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Malposition of Device” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: AS PER PSS IMPLANT REQUEST: RIGHT KNEE INSTABILITY AND PAIN SECONDARY TO VALGUS ALIGNMENT OF TIBIAL COMPONENT. PT HAS A TRIATHLON UNCEMENTED RIGHT TOTAL KNEE REPLACEMENT PLACED IN (B)(6) 2011. SHE HAS A SIZE 5 UNCEMENTED TIBIA, SIZE 5 UNCEMENTED FEMUR AND 9MM CR POLYETHYLENE LINER. THE TIBIAL COMPONENT WAS PLACED IN 5° OF VALGUS MALALIGNMENT AND IS THE CAUSE OF PERSISTENT INSTABILITY IN THE CORONAL PLANE AND PAIN ISSUES FOR WHICH SHE IS VERY UNHAPPY. IT IS VERY WELL FIXED AND WOULD BE VERY DIFFICULT TO REMOVE. FEMORAL ALIGNMENT IS SATISFACTORY) I WOULD LIKE A CUSTOM LINER THAT IS 9MM MEDIALLY AND IS IN 5° OF VARUS TO CORRECT THE MALALIGNMENT.

  Patient problems: Insufficient Information; Joint Laxity; Pain

  MAUDE report 23346348 ↗
• InjuryDec 26, 2019Malposition of Device; Malposition of Device

  KNEE REVISION DUE TO POLY WEAR. UPDATE 28 NOV 2019: ADDITIONAL COMMENT PROVIDED BY CLINICIAN: "REVIEW OF X-RAYS REVEAL THE TIBIAL COMPONENT IS IN 5 DEGREES IN VARUS AND 5 DEGREES IN POSTTRIAL SLOPE. TO MORE ACCURATELY DETERMINE ALIGNMENT, FULL LENGTH X-RAYS WOULD BE REQUIRED."

  Patient problems: Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 9520426 ↗
• InjuryOct 3, 2019Unstable; Malposition of Device; Unintended Movement; Unstable; Malposition of Device; Unintended Movement

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LEFT KNEE, FAILED TOTAL KNEE ARTHROPLASTY." UPDATE TO EVENT DESCRIPTION BASED ON CLINICIAN REVIEW OF THE MEDICAL RECORDS PROVIDED: REGARDING CAUSE OF FAILURE OF THE LEFT KNEE REQUIRING REVISION SURGERY IN (B)(6) 2017, SOME 3-YEARS POST PRIMARY, THERE IS LIMITED INFORMATION. PRIMARY ARTHROPLASTY HAD NO COMPLICATIONS ALTHOUGH AT 3-YEARS FOLLOW-UP THE KNEE WAS DOCUMENTED AS CHRONIC UNSTABLE WITH MID-FLEXION INSTABILITY. THE INSTABILITY WAS CONFIRMED DURING REVISION WHILE ADDITIONALLY THE SURGEON OBSERVED THAT ONLY SOME 20% OF THE TIBIAL BONE INGROWTH SURFACE SHOWED SIGNS OF BONE INGROWTH. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR DEVICES INCLUDING THE PREVIOUSLY UNRESURFACED PATELLA.

  Patient problems: Injury

  MAUDE report 9151362 ↗
• InjuryJun 14, 2019Degraded; Unstable; Malposition of Device; Degraded; Unstable; Malposition of Device

  POLY WEAR ON TRIATHLON KNEE NEED KNEE REVISION. UPDATE BASED ON THE MEDICAL REVIEW, QS 21 MAY 2019: "RELEVANT CLINICAL HISTORY AND TIME LINES" [...] "CLINICAL EXAMINATION AND X-RAYS WERE REPORTED AS ¿NORMAL¿ BUT A DIAGNOSTIC ARTHROSCOPY OF THE LEFT KNEE DOCUMENTED WEAR IN BOTH THE MEDIAL AND LATERAL POSTERIOR SEGMENTS OF THE BEARING. MODERATE INSTABILITY WAS SHOWN DURING ARTHROSCOPY." [...] "CONCLUSION OF ASSESSMENT: BASEPLATE MALPOSITION IN EXCESSIVE POSTERIOR TIBIAL SLOPE OF 10° HAS CONTRIBUTED TO FLEXION INSTABILITY OF THE KNEE ARTHROPLASTY CAUSING THE FEMORAL COMPONENT TO RIDE OVER THE POSTERIOR TIBIAL BEARING BORDER WITH CONSEQUENT POLYETHYLENE WEAR WITH PAIN REQUIRING REVISION SURGERY." [...]

  Patient problems: Injury; Pain

  MAUDE report 8699398 ↗
• InjuryJan 2, 2019Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. REP PROVIDED PRIMARY OPERATIVE AND WEBOPS REPORT, VITALS, AND PRE-REVISION X-RAYS AND REPORTED THAT ADDITIONAL X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY. UPDATE BASED ON CLINICAL REVIEW FINDINGS AR 4DEC2018: COMPLEX MALALIGNMENT OF COMPONENTS INCLUDING AN OBLIQUE JOINT SPACE BETWEEN FEMUR AND TIBIA, LIKELY FEMORAL ROTATORY MALPOSITION AND PATELLOFEMORAL MALALIGNMENT WITH LATERAL TILT/SHIFT HAVE CONTRIBUTED TO AN OVERLOAD CONDITION IN THE PF JOINT RESULTING ULTIMATELY IN DISASSOCIATION BETWEEN PATELLAR METAL-BACKING AND POLY REQUIRING REVISION SURGERY.

  Patient problems: Injury; Pain

  MAUDE report 8209339 ↗