Triathlon 5531-G-516Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327045895), received between Feb 22, 2019 and Feb 20, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2024Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED, THAT THE PATIENT'S LEFT KNEE WAS REVISED, DUE TO PAIN AND FLEXION INSTABILITY. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED, FOR THE INSERT: POSTERIOR MEDIAL CONDYLE WEAR (ALMOST WORN TO THE BASEPLATE IN PARTS), PIECES FRACTURED OFF, AND POSTERIOR LATERAL WEAR AT THE LIP OF THE LINER. THE FEMUR, INSERT, AND TIBIA WERE REVISED TO A TS KNEE WITH STEMS, CONES, AND AUGMENTS WITH A THICKER INSERT. REP CONFIRMED, THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 18744173 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED AN I&D WITH TIBIAL INSERT EXCHANGE ON A LEFT INFECTED KNEE ORIGINALLY DONE APPROXIMATELY 5 YEARS AGO, A TRIATHLON CS KNEE. NO ALLEGATIONS MADE AGAINST THE IMPLANTS. UPDATE 22/FEBRUARY/2022: REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 13757900 ↗
• InjuryJan 12, 2022Unstable; Unstable

  THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2021. IN PROVIDING USAGE SHEETS WHILE REPORTING A REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2021, REP PROVIDED A PRIMARY USAGE SHEET AND A USAGE SHEET FROM A REVISION ON (B)(6) 2021. A 5X16 CS INSERT WAS REVISED TO ANOTHER 5X16 CS INSERT DUE TO FLEXION INSTABILITY. THE REPORTING REP WAS NOT PRESENT FOR THE PROCEDURE AND NO RECORDS EXIST CONFIRMING ANY STRYKER REP WAS PRESENT FOR THE PROCEDURE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 13240094 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT PRIMARY RIGHT KNEE REPLACEMENT ON (B)(6) 2018. PATIENT RETURNED TO HAVE RIGHT KNEE IRRIGATION AND DEBRIDEMENT, POLYETHYLENE LINER EXCHANGE FOR AN ACUTE PERIPROSTHETIC JOINT INFECTION ON (B)(6) 2018 REPORTED AS (B)(4). PATIENT RETURNED TO HAVE IRRIGATION AND DEBRIDEMENT, EXPLANTATION OF ALL COMPONENTS, PLACEMENT OF AN ARTICULATING ANTIBIOTIC SPACER ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 8362012 ↗