Triathlon 5530-G-711Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327045499), received between Apr 9, 2019 and Sep 8, 2025 — classified as 3 injuries, 1 malfunction.

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.

• InjurySep 8, 2025Unstable; Unstable

  REVISION RIGHT TOTAL KNEE REPLACEMENT - ALL IMPLANTS WERE TAKEN OUT AND REPLACED. PATIENT HAD A FALL AFTER INITIAL REPLACEMENT ((B)(6) 2010) & HAD BEEN MANAGED CONSERVATIVELY, HOWEVER INSTABILITY HAD INCREASED AND SURGEON DETERMINED BEST OPTION WAS TO REVISE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 22990131 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED REVISION DUE TO INFECTION. PATIENT ALLEGES A TRIATHLON RIGHT KNEE WAS IMPLANTED ON (B)(6) 2019 WITH THE USE OF TRIATHLON CUTTING GUIDE. PATIENT REPORTED A 1ST STAGE REVISION IN (B)(6) 2019 WITH IRRIGATION & DEBRIDEMENT WHERE ALL PARTS WERE REMOVED. PATIENT REPORTED THE 2ND STAGE REVISION IN (B)(6) 2020 (NOTING "ALL PARTS REMOVED"). PATIENT NOTED COMPETITOR PRODUCT WAS IMPLANTED IN 2021 AND HAS HAD MULTIPLE SURGERIES SINCE. PATIENT NOTED "EXTREME FINANCIAL LOSS, QUALITY OF LIFE, PAIN". PATIENT WOULD LIKE TO KNOW IF ANY STRYKER PARTS ARE SUBJECT TO A RECALL. PATIENT ALLEGES A "SHAPEMATCH" CUTTING GUIDE WAS USED. THIS PI IS FOR I&D & POLY SWAP PERFORMED ON (B)(6) 2019.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14838354 ↗
• InjuryApr 6, 2020Unstable; Noise, Audible; Unstable; Noise, Audible

  AS REPORTED: "CLICKING AND ANTERIOR RIGHT KNEE PAIN. ALL AVAILABLE INFORMATION SUBMITTED." REP PROVIDED AN OFFICE NOTE WHICH REPORTS THE FOLLOWING: "HE HAS HAD PERSISTENT SWELLING IN THE KNEE PROBABLY SINCE SURGERY...DEVELOPED INCREASING DISCOMFORT AND SWELLING IN THE KNEE...A SMALL AMOUNT OF CORONAL INSTABILITY..." THE PATIENT'S INSERT AND PATELLAR COMPONENT WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 9929957 ↗
• MalfunctionApr 9, 2019Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THROUGH A MEDWATCH (MW5084428) ¿PROCEDURE: ROBOTIC-ASSISTED RIGHT TOTAL KNEE ARTHROPLASTY. INTRA-OP NOTE INDICATES IMPLANT BROKE: INSERT TIB KNEE TRIATHLON X3 PLSTC CRUC RETAIN ST. ACTION: IMPLANTED AND EXPLANTED. DESCRIPTION: IMPLANT BROKE.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8496101 ↗