Triathlon 5526-B-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327041354), received between Apr 9, 2018 and Feb 3, 2023 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2023Malposition of Device; Malposition of Device

  "KNEE REVISION DUE TO INSTABILITY" WAS REPORTED. UPDATE 12-JANUARY-2023: PER CLINICIAN REVIEW OF PROVIDED MEDICAL RECORDS, "OVER A 10 YEAR PERIOD THERE WAS SUBSTANTIAL POLYETHYLENE WEAR THAT LED TO REVISION SURGERY DEVICE OR PROCEDURE RELATED ADVERSE EVENT: POLYETHYLENE WEAR LEADING TO INSTABILITY AND REVISION SURGERY. THE TIBIAL COMPONENT WAS PLACED IN SIGNIFICANT VARUS AT THE TIME OF THE PRIMARY SURGERY."

  Patient problems: Joint Laxity

  MAUDE report 16292918 ↗
• InjuryFeb 10, 2020Unstable; Unstable

  KNEE REVISION DUE TO INSTABILITY.

  Patient problems: Injury

  MAUDE report 9688349 ↗
• InjuryJun 20, 2019Unstable; Malposition of Device; Unstable; Malposition of Device

  KNEE REVISION INSTABILITY DUE TO POLY WEAR. UPDATE 24 MAY 2019: CONCLUSION OF THE MEDICAL REVIEW DATED 20 MAY 2019 STATES: BASEPLATE MALPOSITION IN EXCESSIVE POSTERIOR TIBIAL SLOPE OF 12° WITH ADDITIONAL 8° VALGUS DEFORMITY HAVE CONTRIBUTED TO FLEXION INSTABILITY OF THE KNEE ARTHROPLASTY WITH CONSEQUENT POLYETHYLENE WEAR AND CLINICAL SYMPTOMS REQUIRING REVISION SURGERY.

  Patient problems: Injury

  MAUDE report 8716085 ↗
• InjuryNov 7, 2018Unstable; Unstable

  INSTABILITY, POSTERIOR SAGGING AND WEAR OF PROSTHESIS APPROX. 5 YEARS AFTER IMPLANTATION.

  Patient problems: Injury

  MAUDE report 8046138 ↗
• InjurySep 13, 2018Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  KNEE REVISION DUE TO INSTABILITY. UPDATE BASED ON MED REVIEW: BASEPLATE MALPOSITION IN EXCESSIVE POSTERIOR TIBIAL SLOPE HAS CAUSED FLEXION INSTABILITY OF THE KNEE WITH THE FEMORAL COMPONENT RIDING OVER THE POSTERIOR BORDER OF THE BASEPLATE WITH POLY BEARING CAUSING POLY WEAR AND METALLOSIS DUE TO METAL-METAL CONTACT BETWEEN FEMUR AND TIBIA REQUIRING REVISION AFTER 7-YEARS.

  Patient problems: Injury

  MAUDE report 7874091 ↗
• InjuryJul 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD RIGHT KNEE SURGERY DONE ON (B)(6) 2013 AND WAS REVISED ON (B)(6) 2018 DUE TO LITTLE BONE GROWTH. PATIENT WAS REVISED TO NON STRYKER IMPLANTS.

  Patient problems: Injury

  MAUDE report 7654920 ↗
• InjuryMay 23, 2018Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  PATIENT NEED KNEE REVISION THE REASON IS ¿INSTABILITY¿ IN THE KNEE.

  Patient problems: Injury

  MAUDE report 7537886 ↗
• InjuryApr 9, 2018Malposition of Device; Malposition of Device

  PATIENT VISIT OUT CLINIC WITH PAIN AND INSTABILITY. UPDATE: BASED ON THE MEDICAL REVIEW THE FEMORAL COMPONENT MALPOSITION IN POSTERIOR POSITION PLUS EXCESSIVE DISTAL FEMORAL BONE RESECTION IN COMBINATION WITH BASEPLATE MALPOSITION IN EXCESSIVE POSTERIOR SLOPE OF 11° HAS CONTRIBUTED TO COMPLEX AND GLOBAL KNEE INSTABILITY WITH PAIN SYMPTOMS REQUIRING REVISION.

  Patient problems: Injury; Pain

  MAUDE report 7406184 ↗